Elecsys IGFBP-3 07574690190Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07613336142677), received between Dec 7, 2022 and Aug 4, 2023 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “High Test Results” (1 report).

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 16, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 4, 2023Low Test Results; Low Test Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS IGFBP-3 RESULTS FOR 8 PATIENT SAMPLES ON A COBAS E 411 IMMUNOASSAY ANALYZER. THE DOCTOR QUESTIONED THE RESULTS AS THEY DID NOT MEET THE PATIENTS' CLINICAL PICTURES. ON (B)(6) 2023, PATIENT 1 HAD AN IGFBP-3 RESULT OF 4493 NG/ML. ON (B)(6) 2023, PATIENT 2 HAD AN IGFBP-3 RESULT OF 4650 NG/ML. ON (B)(6) 2023, PATIENT 3 HAD AN IGFBP-3 RESULT OF 2279 NG/ML. ON (B)(6) 2023, PATIENT 4 HAD AN IGFBP-3 RESULT OF 3227 NG/ML. ON (B)(6) 2023, PATIENT 5 HAD AN IGFBP-3 RESULT OF 1171 NG/ML. ON (B)(6) 2023, PATIENT 6 HAD AN IGFBP-3 RESULT OF 5436 NG/ML. ON (B)(6) 2023, PATIENT 7 HAD AN IGFBP-3 RESULT OF 3022 NG/ML. ON (B)(6) 2023, PATIENT 8 HAD AN IGFBP-3 RESULT OF 5124 NG/ML.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17465221 ↗
• InjuryDec 7, 2022Product Quality Problem; Incorrect, Inadequate or Imprecise Result or Readings; Improper or Incorrect Procedure or Method; High Test Results; Product Quality Problem; Incorrect, Inadequate or Imprecise Result or Readings; Improper or Incorrect Procedure or Method; High Test Results

  WE RECEIVED AN ALLEGATION THAT THE ELECSYS IGFBP-3 ASSAY AND ELECSYS IGF-1 ASSAY RESULTS MAY HAVE CONTRIBUTED TO A NEGATIVE IMPACT ON PATIENTS' GROWTH AND THE PATIENTS WERE REPORTEDLY NOT PROGRESSING AS EXPECTED. THIS MDR IS FOR THE ELECSYS IGFBP-3 ASSAY. REFER TO MDR WITH PATIENT IDENTIFIER: (B)(6) FOR THE ELECSYS IGF-1 ASSAY. THE REPORTER STATED THAT PEDIATRIC ENDOCRINOLOGISTS HAVE RAISED A CONCERN ABOUT THE IGF-1 AND IGFBP3 RESULTS. THEY REPORTEDLY NOTICED THAT THE VALUES HAVE BEEN HIGHER THAN THE PREVIOUS METHOD (THE IMMULITE) AND HAVE BEEN REPORTEDLY TREATING THEIR PATIENTS BASED ON THE HIGHER RESULTS. THE REPORTER STATED THAT DURING VALIDATION PRIOR TO CHANGING TO THE ROCHE METHOD, THE E411 WAS REPORTEDLY RUNNING HIGHER THAN THE IMMULITE. MOST SAMPLES REPORTEDLY STAYED WITHIN OR OUTSIDE OF THE REFERENCE RANGE. THE REPORTER STATED THAT THEY THOUGHT THAT THE PREVIOUS SYSTEM WAS TOO LOW, NOT THAT THE ROCHE WAS TOO HIGH. THE REPORTER STATED THEY HAD CHANGED THE REFERENCE RANGE TO REFLECT THE ROCHE REFERENCE RANGE. THIS REPORTEDLY HAD INCREASED SLIGHTLY FROM THE PREVIOUS METHODOLOGY. THE REPORTER WENT ON TO STATE THAT AFTER THE PHYSICIANS TREATED THEIR PATIENTS BASED ON ROCHE'S RE

  Patient problems: Hormonal Imbalance; Insufficient Information

  MAUDE report 15933869 ↗