Tina-quant Lipoprotein (a) Gen.2 08106126190Recalls & reported problems

Summary

The FDA's MAUDE database contains 28 adverse event reports that list this exact device (DI 07613336140833), received between Aug 24, 2023 and Sep 8, 2026 — classified as 28 malfunctions.

The most frequently reported specific device problem is “High Test Results” (22 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 28 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 8, 2026Incorrect Measurement; Non Reproducible Results

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50675835 ↗
• MalfunctionJun 11, 2026Low Test Results

  THE INITIAL REPORTER RECEIVED QUESTIONABLE TINA-QUANT LIPOPROTEIN (A) GEN.2 ASSAY RESULTS FROM 2 PATIENT SAMPLES TESTED ON THE COBAS INTEGRA 400 PLUS. PATIENT SAMPLE 1 THE INITIAL RESULT FROM THE ANALYZER WAS 31.9 MG/DL. THE REPEAT RESULT FROM A REFERENCE LABORATORY USING THE ABBOTT ALINITY WAS 50.4 MG/DL. PATIENT SAMPLE 2 THE INITIAL RESULT FROM THE ANALYZER WAS 23.8 MG/DL. THE REPEAT RESULT FROM A REFERENCE LABORATORY USING THE ABBOTT ALINITY WAS 38.3 MG/DL. THE PHYSICIAN QUESTIONED THE INITIAL RESULTS, AS THEY DID NOT MATCH THE PATIENTS' MEDICAL HISTORIES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25467156 ↗
• MalfunctionMar 17, 2026High Test Results; Low Readings; Calibration Problem

  WE RECEIVED AN ALLEGATION OF QC ISSUES AND A DISCREPANT HIGH RESULT FOR 1 PATIENT SAMPLE TESTED FOR TINA-QUANT LIPOPROTEIN (A) GEN.2 (LPA2) ON A COBAS C 503 ANALYTICAL UNIT THE INITIAL RESULT WAS 220 NMOL/L. THE REPEAT RESULT WAS 125 NMOL/L.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24619726 ↗
• MalfunctionNov 6, 2025High Test Results; Non Reproducible Results; High Test Results; Non Reproducible Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE TINA-QUANT LIPOPROTEIN (A) (LPA) GEN.2 RESULTS FOR 8 PATIENT SAMPLES ON A COBAS C 503 ANALYTICAL UNIT. THE CUSTOMER HAS BEEN REPEATING LPA TESTING SINCE (B)(6) 2023 DUE TO ONGOING ISSUES. ON (B)(6) 2025, SAMPLE 1 HAD AN INITIAL RESULT OF 33.8 MG/DL WITH FLAG. THE REPEAT RESULT WAS 18.8 MG/DL. ON (B)(6) 2025, SAMPLE 2 HAD AN INITIAL RESULT OF 93.4 MG/DL ACCOMPANIED BY A FLAG INDICATING THE VALUE IS ABOVE THE LINEARITY/MEASURING RANGE OF THE ASSAY. THE REPEAT RESULT WAS 45.0 MG/DL WITH FLAG. ON (B)(6) 2025, SAMPLE 3 HAD AN INITIAL RESULT OF 24 MG/DL WITH FLAG. THE SAMPLE WAS REPEATED TWICE AND THE RESULTS WERE 93.4 MG/DL ACCOMPANIED BY A FLAG INDICATING THE VALUE IS ABOVE THE LINEARITY/MEASURING RANGE OF THE ASSAY AND 32 MG/DL. ON (B)(6) 2025, SAMPLE 4 HAD AN INITIAL RESULT OF 25 MG/DL WITH FLAG. THE REPEAT RESULT WAS 46 MG/DL. ON (B)(6) 2025, SAMPLE 5 HAD AN INITIAL RESULT OF 95 MG/DL ON MODULE 1. AN AUTOMATIC 1:3 DILUTION WAS PERFORMED ON THE SAMPLE AND THE REPEAT RESULT WAS 32 MG/DL. THE SAMPLE WAS REPEATED TWICE ON MODULE 2 AND THE RESULT WAS 27 MG/DL AND 24 MG/DL. THE SAMPLE WAS REPEATED AGAIN ON MODULE 1 AND THE RESULT WAS 30 MG/DL. ON (B

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23488026 ↗
• MalfunctionSep 17, 2025High Test Results; High Test Results

  THERE WAS AN ALLEGATION OF A QUESTIONABLE TINA-QUANT LIPOPROTEIN (A) GEN.2 RESULT FROM THE COBAS C 503 ANALYTICAL UNIT FOR ONE PATIENT. THE INITIAL RESULT WAS 55 MG/DL. THE FIRST AND SECOND REPEAT RESULTS WERE 23 MG/DL. THE THIRD REPEAT RESULT WAS 44 MG/DL. THE FOURTH AND FIFTH REPEAT RESULTS FROM ANOTHER ANALYZER WERE 23 MG/DL. THE RESULT OF 23 MG/DL WAS DEEMED TO BE CORRECT. THE QUESTIONABLE RESULT WAS REPEATED AS THE CUSTOMER WAS INVESTIGATING FLIERS AS THIS HAD BEEN A RECURRING ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23076298 ↗
• MalfunctionAug 13, 2025Incorrect Measurement; Incorrect Measurement

  THE INITIAL REPORTER RECEIVED QUESTIONABLE TINA-QUANT LIPOPROTEIN (A) GEN.2 RESULTS FROM PATIENT SAMPLES TESTED ON THE COBAS C 503 ANALYTICAL UNIT. THE INITIAL RESULT WAS 56 MG/DL. THE FIRST REPEAT RESULT WAS 85 MG/DL WITH AN INVALIDATING DATA FLAG. THE SECOND REPEAT RESULT WAS 33 MG/DL. THIS REPEAT RESULT WAS DEEMED CORRECT. THE THIRD REPEAT RESULT WAS 36 MG/DL. THE FOURTH REPEAT RESULT WAS 33 MG/DL. THE INITIAL RESULT WAS NOT REPORTED OUTSIDE OF THE LABORATORY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22792404 ↗
• MalfunctionJul 21, 2025High Test Results; High Test Results

  THERE WAS AN ALLEGATION OF A QUESTIONABLE TINA-QUANT LIPOPROTEIN (A) GEN.2 RESULT FROM THE COBAS C 503 ANALYTICAL UNIT. THE INITIAL RESULT FOR SAMPLE (B)(6) ON (B)(6) 2025 WAS 31 MG/DL, AND A REPEAT RESULT OF 26 MG/DL. THERE WAS ANOTHER REPEAT RESULT OF 15 MG/DL FROM ANOTHER ANALYZER. WITH ADDITIONAL REPEAT RESULTS ON (B)(6) 2025 OF 15 MG/DL FROM ANOTHER ANALYZER AND A RESULT OF 14 MG/DL FROM THE INITIAL ANALYZER. THE INITIAL RESULT FOR SAMPLE (B)(6) ON (B)(6) 2025 WAS 116 MG/DL, AND A REPEAT RESULT OF 56 MG/DL. THERE WERE TWO ADDITIONAL REPEAT RESULTS OF 50 MG/DL AND 49 MG/DL FROM ANOTHER ANALYZER. ON (B)(6) 2025, ON THE SAME INITIAL ANALYZER, THERE WAS A RESULT OF 48 MG/DL. THE INITIAL RESULT FOR SAMPLE (B)(6) ON (B)(6) 2025 WAS 38 MG/DL, AND A REPEAT RESULT OF 32 MG/DL. THERE WERE 2 ADDITIONAL REPEAT RESULTS FROM ANOTHER ANALYZER OF 21 MG/DL AND 21 MG/DL. THERE WAS ALSO AN ADDITIONAL REPEAT RESULT FROM THE INITIAL ANALYZER OF 22 MG/DL. THE QUESTIONABLE RESULTS WERE NOT RELEASED OUTSIDE OF THE LABORATORY. THE INITIAL RESULTS WERE REPEATED BECAUSE THE CUSTOMER QUESTIONED THEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22554045 ↗
• MalfunctionFeb 24, 2025High Test Results; Non Reproducible Results; High Test Results; Non Reproducible Results

  WE RECEIVED AN ALLEGATION ABOUT DISCREPANT RESULTS FOR AN UNSPECIFIED NUMBER OF PATIENT SAMPLES TESTED WITH TINA-QUANT LIPOPROTEIN (A) GEN.2 (LPA2) ASSAY ON A COBAS C503 ANALYTICAL UNIT. THE FOLLOWING EXAMPLES OF DISCREPANT RESULTS WERE PROVIDED: SAMPLE 1: INITIAL RESULT FROM THE ANALYZER: 78 MG/DL 1ST REPEAT RESULT FROM THE ANALYZER: 62 MG/DL. 2ND AND 3RD REPEAT RESULTS FROM ANOTHER C 503 ANALYZER: BOTH 50 MG/DL. 4TH AND 5TH REPEAT RESULTS FROM THE ANALYZER: BOTH 50 MG/DL. SAMPLE 2: INITIAL RESULT FROM THE ANALYZER: 62 MG/DL 1ST REPEAT RESULT FROM THE ANALYZER: 48 MG/DL. 2ND REPEAT RESULT FROM THE OTHER C503 ANALYZER: 30 MG/DL. 3RD REPEAT RESULT FROM THE OTHER C503 ANALYZER: 28 MG/DL. 4TH REPEAT RESULT FROM THE ANALYZER: 29 MG/DL. SAMPLE 3: INITIAL RESULT FROM THE ANALYZER: 80 MG/DL. 1ST REPEAT RESULT FROM THE ANALYZER: 62 MG/DL. 2ND AND 3RD REPEAT RESULTS FROM THE OTHER C503 ANALYZER: BOTH 49 MG/DL. THE REPEAT RESULTS WERE DEEMED TO BE CORRECT. NO QUESTIONABLE RESULTS WERE REPORTED OUTSIDE THE LABORATORY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21453152 ↗
• MalfunctionDec 26, 2024Degraded; Incorrect, Inadequate or Imprecise Result or Readings; High Test Results; Degraded; Incorrect, Inadequate or Imprecise Result or Readings; High Test Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE TINA-QUANT LIPOPROTEIN (A) GEN. 2 RESULTS FROM THE COBAS C 503 ANALYTICAL UNIT. SAMPLE 1 INITIAL RESULT WAS 80 MG/DL AND THE REPEAT RESULT WAS 49 MG/DL. SAMPLE 2 INITIAL RESULT WAS 35 MG/DL AND THE REPEAT RESULT WAS 19 MG/DL. NO QUESTIONABLE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THE REPEAT RESULTS WERE BELIEVED TO BE CORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21019046 ↗
• MalfunctionDec 26, 2024Incorrect, Inadequate or Imprecise Result or Readings; High Test Results; Chemical Problem; Device Ingredient or Reagent Problem; Incorrect, Inadequate or Imprecise Result or Readings; High Test Results; Chemical Problem; Device Ingredient or Reagent Problem

  THERE WAS AN ALLEGATION OF QUESTIONABLE TINA-QUANT LIPOPROTEIN (A) GEN. 2 RESULTS FROM THE COBAS C 503 ANALYTICAL UNIT. SAMPLE 1 INITIAL RESULT WAS 87 MG/DL AND THE REPEAT RESULT WAS 42 MG/DL. SAMPLE 2 INITIAL RESULT WAS 61 MG/DL AND THE REPEAT RESULT WAS 26 MG/DL. NO QUESTIONABLE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THE REPEAT RESULT WAS BELIEVED TO BE CORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21019039 ↗
• MalfunctionDec 3, 2024High Test Results; High Test Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE TINA-QUANT LIPOPROTEIN (A) GEN. 2 RESULTS FOR THREE PATIENT SAMPLES ON A COBAS C 503 ANALYTICAL UNIT. AN EXAMPLE OF DISCREPANT RESULTS: THE INITIAL RESULT WAS 44 MG/DL. THE SAMPLE WAS REPEATED ON ANOTHER MODULE. THE REPEATED RESULTS WERE 26 MG/DL AND 27 MG/DL. THE RESULT OF 27 MG/DL WAS BELIEVED TO BE CORRECT. THE SAMPLE WAS REPEATED DUE TO THE CUSTOMER PERFORMING DUPLICATE TESTING FOR LIPOPROTEIN RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20833967 ↗
• MalfunctionNov 22, 2024High Test Results; Non Reproducible Results; High Test Results; Non Reproducible Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE LPA2 TINA-QUANT LIPOPROTEIN (A) GEN.2 RESULTS FOR 3 PATIENT SAMPLES ON TWO COBAS C 503 ANALYTICAL UNIT. THE CUSTOMER HAD BEEN HAVING ISSUES WITH HIGH LPA2 RESULTS FOR SEVERAL MONTHS WHICH PROMPTED THEM TO REPEAT THE PATIENT SAMPLES. ON (B)(6) 2024, SAMPLE 1 HAD AN INITIAL PLASMA LPA RESULT OF135 MG/DL ON ANALYZER SERIAL NUMBER (B)(6). THE SAMPLE WAS REPEATED THREE TIMES AND THE RESULTS WERE 108 MG/DL, 42 MG/DL WITH AN AUTOMATIC 1:3 DECREASED DILUTION, AND 60 MG/DL. THE SAMPLE WAS ALSO REPEATED TWICE ON ANALYZER SERIAL NUMBER (B)(6) AND THE RESULTS WERE 33 MG/DL AND 38 MG/DL. THE RESULT OF 38 MG/DL WAS DEEMED CORRECT. ON (B)(6) 2024, SAMPLE 2 HAD AN INITIAL PLASMA LPA RESULT OF 73 MG/DL ON ANALYZER SERIAL NUMBER (B)(6). THE SAMPLE WAS REPEATED AND THE RESULT WAS 57 MG/DL. ON(B)(6) 2024, THE SAMPLE WAS REPEATED TWICE ON ANALYZER SERIAL NUMBER (B)(6) AND THE RESULTS WERE 25 MG/DL AND 24 MG/DL. THE SAMPLE WAS REPEATED ON ANALYZER SERIAL NUMBER (B)(6) AGAIN AND THE RESULT WAS 24 MG/DL. THE RESULT OF 24 MG/DL WAS DEEMED CORRECT. ON (B)(6) 2024, SAMPLE 3 HAD AN INITIAL SERUM LPA RESULT OF 135 MG/DL ON ANALYZER SERIAL NUMBER (B)(6). THE SAMPLE WAS RE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20758395 ↗
• MalfunctionSep 26, 2024Incorrect, Inadequate or Imprecise Result or Readings; High Test Results; Incorrect, Inadequate or Imprecise Result or Readings; High Test Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE LPA2 TINA-QUANT LIPOPROTEIN (A) GEN.2 RESULTS FOR SEVERAL PATIENT PLASMA SAMPLES ON A COBAS PURE C 303 ANALYTICAL UNIT. THE CUSTOMER PROVIDED EXAMPLES FOR 2 PATIENT SAMPLES. ON (B)(6) 2024, SAMPLE 1 HAD AN INITIAL LPA2 RESULT ACCOMPANIED BY A FLAG INDICATING THE VALUE IS ABOVE THE LINEARITY/MEASURING RANGE OF THE ASSAY. THE SAMPLE WAS REPEATED AND THE RESULT WAS 707 NMOL/L. THE CUSTOMER QUESTIONED THE RESULT AS IT DID NOT MATCH THE PATIENT'S CLINICAL HISTORY. ON (B)(6) 2024, THE SAMPLE WAS REPEATED AND THE RESULT WAS 437 NMOL/L ACCOMPANIED BY A FLAG INDICATING THE VALUE IS ABOVE THE LINEARITY/MEASURING RANGE OF THE ASSAY. THE SAMPLE WAS AUTO-REPEATED AND THE RESULT WAS 493 NMOL/L. A 1:3 DILUTION WAS MADE FROM THE PATIENT SAMPLE AND TESTED AND THE RESULT WAS 441 NMOL/L. THE PATIENT ALSO HAD ANOTHER SAMPLE RESULT OF 669 NMOL/L. CLARIFICATION ON THE DATE OF TESTING AND IF IT WAS OBTAINED FROM A SAMPLE FROM THE SAME COLLECTION WAS REQUESTED BUT NOT PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20313080 ↗
• MalfunctionAug 28, 2024Incorrect Measurement; Non Reproducible Results; Incorrect Measurement; Non Reproducible Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE TINA-QUANT LIPOPROTEIN (A) GEN. 2 RESULTS FROM THE COBAS C 503 ANALYTICAL UNIT. THE INITIAL RESULT WAS 38 MG/DL. THE REPEAT RESULT WAS 80 MG/DL. THE QUESTIONABLE RESULT WAS NOT REPORTED OUTSIDE OF THE LABORATORY. THE CUSTOMER WAS NOT SURE WHICH RESULT WAS CORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20091108 ↗
• MalfunctionJun 11, 2024Incorrect Measurement; Non Reproducible Results; Incorrect Measurement; Non Reproducible Results

  THE INITIAL REPORTER COMPLAINED OF DISCREPANT RESULTS FOR 1 PATIENT SAMPLE TESTED FOR TINA-QUANT LIPOPROTEIN (A) GEN. 2 (LPA2) ON A COBAS C 503 ANALYTICAL UNIT. THE INITIAL RESULT WAS 47 MG/DL. THE REPEAT RESULT WAS 21 MG/DL. THE INITIAL RESULT WAS NOT REPORTED OUTSIDE OF THE LABORATORY. THE REPEAT RESULT WAS BELIEVED TO BE CORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19513949 ↗
• MalfunctionJun 3, 2024High Test Results; Non Reproducible Results; High Test Results; Non Reproducible Results

  THE INITIAL REPORTER COMPLAINED OF DISCREPANT RESULTS FOR 2 PATIENT SAMPLES TESTED FOR TINA-QUANT LIPOPROTEIN (A) GEN. 2 (LPA2) ON A COBAS C 503 ANALYTICAL UNIT. "PATIENT 2" INITIAL RESULT WAS 58 MG/DL. THE SAMPLE WAS REPEATED 6 TIMES WITH RESULTS OF 46 MG/DL, 36 MG/DL, 31 MG/DL, 31 MG/DL, 30 MG/DL AND 30 MG/DL. "PATIENT 3" INITIAL RESULT WAS 79 MG/DL. THE SAMPLE WAS REPEATED 3 TIMES WITH RESULTS OF 46 MG/DL, 41 MG/DL, AND 42 MG/DL. NO QUESTIONABLE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY; THE CUSTOMER IS RUNNING PATIENT SAMPLES IN DUPLICATE. THE REPEAT RESULTS WERE BELIEVED TO BE CORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19447993 ↗
• MalfunctionMay 16, 2024High Test Results; Non Reproducible Results; High Test Results; Non Reproducible Results

  THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR ONE PATIENT SAMPLE TESTED WITH TINA-QUANT LIPOPROTEIN (A) GEN. 2 ON A COBAS C 503 ANALYTICAL UNIT. NO QUESTIONABLE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THE USER HAS BEEN REPEATING ALL LIPOPROTEIN (A) TESTING IN DUPLICATE DUE TO ONGOING ISSUES. THE SAMPLE INITIALLY RESULTED IN A LIPOPROTEIN (A) VALUE OF 76.9 MG/DL WITH A DATA FLAG. THE SAMPLE WAS REPEATED TWICE ON THE SAME ANALYZER, RESULTING IN LIPOPROTEIN (A) VALUES OF 62.7 MG/DL WITH A DATA FLAG AND 46.9 MG/DL WITH A DATA FLAG. THE REPEAT VALUE OF 46.9 MG/DL WAS DEEMED CORRECT. THE SAMPLE WAS REPEATED TWICE ON A SECOND ANALYZER, RESULTING IN LIPOPROTEIN (A) VALUES OF 53 MG/DL WITH A DATA FLAG AND 52 MG/DL WITH A DATA FLAG.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19332816 ↗
• MalfunctionApr 9, 2024High Test Results; High Test Results

  THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR TWO PATIENT SAMPLES TESTED WITH TINA-QUANT LIPOPROTEIN (A) GEN. 2 ON A COBAS C 503 ANALYTICAL UNIT. NO QUESTIONABLE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THE INITIAL VALUES WERE ACCOMPANIED BY DATA FLAGS AND THE SAMPLES WERE THEN AUTOMATICALLY REPEATED ON THE ANALYZER. THE FIRST SAMPLE INITIALLY RESULTED IN A LIPOPROTEIN (A) VALUE OF 58 MG/DL AND IT AUTOMATICALLY REPEATED AS 49 MG/DL. THE SAMPLE WAS REPEATED TWICE ON A SECOND ANALYZER, RESULTING IN VALUES OF 28 MG/DL AND 29 MG/L. THE SAMPLE WAS ALSO REPEATED ON THE COMPLAINED ANALYZER, RESULTING IN A VALUE OF 28 MG/DL. THE 28 MG/DL VALUE WAS DEEMED CORRECT. THE SECOND SAMPLE INITIALLY RESULTED IN A LIPOPROTEIN (A) VALUE OF 79 MG/DL AND IT AUTOMATICALLY REPEATED AS 65 MG/DL. THE SAMPLE WAS REPEATED TWICE ON A SECOND ANALYZER, RESULTING IN VALUES OF 52 MG/DL AND 52 MG/L. THE 52 MG/DL VALUE WAS DEEMED CORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19073830 ↗
• MalfunctionApr 3, 2024High Test Results; Non Reproducible Results; High Test Results; Non Reproducible Results

  THE INITIAL REPORTER RECEIVED QUESTIONABLE TINA-QUANT LIPOPROTEIN (A) GEN.2 (LPA2) RESULTS FROM ONE PATIENT SAMPLE TESTED ON THE COBAS PRO C 503 ANALYTICAL UNIT. THE INITIAL RESULT WAS NOT REPORTED OUTSIDE OF THE LABORATORY. THE REPORTER STATED THEY RERUN THE PATIENT SAMPLES FOR THE ASSAY IN DUPLICATE. ON (B)(6) 2024: THE INITIAL RESULT FROM THE LINE 2 WAS 48 MG/DL. THE FIRST REPEAT RESULT FROM LINE 2 WAS 57 MG/DL. THE SECOND REPEAT RESULT FROM LINE 1 WAS 30 MG/DL. ON (B)(6) 2024: THE THIRD REPEAT RESULT FROM LINE 1 WAS 30 MG/DL. THE RESULT OF 30 MG/DL WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19032282 ↗
• MalfunctionMar 22, 2024Non Reproducible Results; Non Reproducible Results

  THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR ONE PATIENT SAMPLE TESTED WITH LPA2 (LIPOPROTEIN A) ON A COBAS C 503 ANALYTICAL UNIT. NO QUESTIONABLE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THE SAMPLE INITIALLY RESULTED IN A LIPOPROTEIN A VALUE OF 52.1 MG/DL WITH A DATA FLAG. THE SAMPLE WAS AUTOMATICALLY REPEATED BY THE ANALYZER, RESULTING IN A VALUE OF 46 MG/DL. THE SAMPLE WAS REPEATED THREE TIMES ON A SECOND ANALYZER, RESULTING IN VALUES OF 35 MG/DL, 35 MG/DL, AND 34.0 MG/DL WITH A DATA FLAG. THE REPEAT VALUE OF 35 MG/DL WAS DEEMED CORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18959781 ↗
• MalfunctionFeb 14, 2024High Test Results; High Test Results

  THE INITIAL REPORTER RECEIVED A QUESTIONABLE TINA-QUANT LIPOPROTEIN (A) GEN.2 (LPA2) RESULT FROM ONE PATIENT SAMPLE TESTED ON THE COBAS PRO C 503 ANALYTICAL UNIT. THE INITIAL RESULT WAS NOT REPORTED OUTSIDE OF THE LABORATORY. THE REPORTER STATED THEY RERUN THE PATIENT SAMPLES FOR THE ASSAY AT LEAST IN DUPLICATE. THE REPORTED LINE IS LINE 1. THE INITIAL RESULT FROM THE LINE 1 WAS 81 MG/DL. THE FIRST REPEAT RESULT FROM LINE 1 WAS 54 MG/DL. THE SECOND REPEAT RESULT FROM LINE 2 WAS 49 MG/DL. THE THIRD REPEAT RESULT FROM LINE 2 WAS 49 MG/DL. THE FOURTH REPEAT RESULT FROM LINE 1 WAS 49 MG/DL. THE FIFTH REPEAT RESULT FROM LINE 1 WAS 49 MG/DL. THIS RESULT WAS DEEMED CORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18702935 ↗
• MalfunctionJan 25, 2024Incorrect, Inadequate or Imprecise Result or Readings; High Test Results; Incorrect, Inadequate or Imprecise Result or Readings; High Test Results

  THE INITIAL REPORTER RECEIVED QUESTIONABLE TINA-QUANT LIPOPROTEIN (A) GEN.2 (LPA2) RESULTS FROM TWO PATIENT SAMPLES TESTED ON THE COBAS PRO C 503 ANALYTICAL UNIT. THE REPORTER WAS ABLE TO PROVIDE ONE PATIENT SAMPLE WITH DISCREPANT RESULTS. THE INITIAL RESULT WAS NOT REPORTED OUTSIDE OF THE LABORATORY. THE PATIENT SAMPLE WAS RERUN ON THEIR OTHER COBAS PRO ANALYZER. THE INITIAL RESULT FROM THE ANALYZER WAS (B)(6) WITH A DATA FLAG. THE FIRST REPEAT RESULT FROM THE ANALYZER WAS (B)(6) WITH A DATA FLAG. THE SECOND REPEAT FROM THE OTHER ANALYZER RESULT WAS (B)(6) WITH A DATA FLAG. THE THIRD REPEAT RESULT FROM THE OTHER ANALYZER WAS (B)(6) WITH A DATA FLAG. THE REPEAT RESULTS FROM THE OTHER ANALYZER WERE DEEMED CORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18578951 ↗
• MalfunctionNov 17, 2023High Test Results; Non Reproducible Results; High Test Results; Non Reproducible Results

  THE INITIAL REPORTER COMPLAINED OF A DISCREPANT HIGH RESULT FOR 1 PATIENT SAMPLE TESTED FOR LPA2 ON A COBAS C 503 ANALYTICAL UNIT. THE INITIAL RESULT WAS 32 MG/DL WITH A DATA FLAG. THE CUSTOMER IS REPEATING ALL SAMPLES WITH HIGH LPA2 RESULTS. THE REPEAT RESULTS WERE 27 MG/DL, 19 MG/DL, 19 MG/DL, 20 MG/DL AND 20 MG/DL. THE REPEAT RESULTS OF 19 MG/DL AND 20 MG/DL WERE BELIEVED TO BE CORRECT. NO QUESTIONABLE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18158626 ↗
• MalfunctionNov 15, 2023High Test Results; Chemical Problem; Improper Chemical Reaction; Non Reproducible Results; High Test Results; Chemical Problem; Improper Chemical Reaction; Non Reproducible Results

  THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR ONE PATIENT SAMPLE TESTED WITH LPA2 (LIPOPROTEIN A) ON A COBAS PRO C 503 ANALYTICAL UNIT. NO QUESTIONABLE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THE CUSTOMER HAD BEEN RUNNING SAMPLES IN DUPLICATE DUE TO ONGOING ISSUES. THE SAMPLE INITIALLY RESULTED IN A LIPOPROTEIN A VALUE OF > 67 MG/DL ACCOMPANIED BY A DATA FLAG. THE SAMPLE WAS REPEATED WITH A X3 AUTOMATIC DILUTION, RESULTING IN A LIPOPROTEIN A VALUE OF 63 MG/DL. THE SAMPLE WAS REPEATED A SECOND TIME, RESULTING IN A LIPOPROTEIN A VALUE OF 131 MG/DL. THE SAMPLE WAS REPEATED THREE ADDITIONAL TIMES, RESULTING IN LIPOPROTEIN A VALUES OF 71 MG/DL, 65 MG/DL, AND 65 MG/DL. THE SAMPLE WAS REPEATED TWICE ON A SECOND ANALYZER, RESULTING IN LIPOPROTEIN A VALUES OF 73 MG/DL AND 64 MG/DL. THE SAMPLE WAS REPEATED TWO ADDITIONAL TIMES ON THE SECOND ANALYZER ON 16-OCT-2023, RESULTING IN LIPOPROTEIN A VALUES OF 66 MG/DL AND 63 MG/DL. THE VALUE OF 63 MG/DL WAS DEEMED CORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18144316 ↗
• MalfunctionNov 14, 2023Unable to Obtain Readings; High Test Results; Chemical Problem; Improper Chemical Reaction; Non Reproducible Results; Unable to Obtain Readings; High Test Results; Chemical Problem; Improper Chemical Reaction; Non Reproducible Results

  THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR ONE PATIENT SAMPLE TESTED WITH LPA2 (LIPOPROTEIN A) ON A COBAS PRO C 503 ANALYTICAL UNIT. NO QUESTIONABLE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THE CUSTOMER HAD BEEN TESTING ALL SAMPLES IN DUPLICATE DUE TO CONSISTENT ISSUES. THE SAMPLE INITIALLY RESULTED IN A LIPOPROTEIN A VALUE OF 47 MG/DL AND IT REPEATED AS 142 MG/DL. THE VALUE OF 47 MG/DL WAS DEEMED CORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18129431 ↗