RealTime 08N90-090Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00884999047358), received between Jan 21, 2020 and Sep 9, 2022 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “False Negative Result” (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. How this data works · Data updated Oct 13, 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.

• InjurySep 9, 2022False Negative Result; False Negative Result

  THE CUSTOMER REPORTED ONE FALSE NEGATIVE RESULT ON THE ABBOTT REALTIME IDH1 ASSAY. THE CUSTOMER REPORTED A DISCREPANT RESULT FOR THE R132H MUTATION WHILE USING THE ABBOTT REALTIME IDH1 ASSAY. SAMPLE ID (SID) (B)(6) WAS TESTED ON (B)(6) 2022, AND THE RESULT WAS "NOT DETECTED" FOR THE R132H MUTATION. THE NEGATIVE RESULT WAS REPORTED TO THE PATIENT'S PHYSICIAN. THE PHYSICIAN CONTACTED THE CUSTOMER'S LABORATORY TO LET THEM KNOW THAT THE PATIENT'S SAMPLE WAS RE-TESTED AT A DIFFERENT LABORATORY AND THE RESULT WAS "DETECTED: FOR THE R132H MUTATION. IT IS NOT KNOWN WHY THE PHYSICIAN QUESTIONED THE RESULT AND HAD ANOTHER TEST PERFORMED AT A DIFFERENT LABORATORY. THE SAMPLE WAS THEN RETESTED USING THREE DIFFERENT SAMPLES IN THE CUSTOMER'S LABORATORY ON (B)(6) 2022. THE THREE SAMPLES WERE THE ORIGINAL EXTRACTED MATERIAL, FRESHLY EXTRACTED MATERIAL FROM THE ORIGINAL PATIENT SAMPLE VIAL (SID (B)(6)), AND MATERIAL PROVIDED BY THE OUTSIDE LABORATORY (SID (B)(6)). ALL THREE SAMPLES (FROM THE SAME PATIENT) HAD MUTATION R132H DETECTED. THE EFFECT ON THE PATIENT'S HEALTH MANAGEMENT IS NOT KNOWN. A MEDICAL OPINION WAS OBTAINED FOR THE POTENTIAL DELAY IN TREATMENT FOR > 5 DAYS AND CONCLUDED IN A WORST-

  Patient problems: Insufficient Information

  MAUDE report 15392990 ↗
• MalfunctionJan 21, 2020Non Reproducible Results; Non Reproducible Results

  CUSTOMER ALLEGES DISCREPANT RESULTS WHEN RUNNING THE REALTIME IDH1 ASSAY. CUSTOMER ORIGINALLY TESTED PATIENT SAMPLE ID DL-19-82019 ON (B)(6) 2019 WITH RESULT R132C DETECTED (NEAR THE THRESHOLD CYCLE). PATIENT SAMPLE WAS REPORTED AS R132C. ON (B)(6) 2019, CUSTOMER TESTED SAMPLE PATIENT EXTRACTION AS PART OF INTERNAL VALIDATION AND IT GENERATED A RESULTED OF NOT DETECTED (THIS TIME RESULT FOR R132G WAS NEAR THE THRESHOLD CYCLE). CUSTOMER CONTINUED TO TEST THE SAMPLE AS RESULTS WERE ERRATIC. FOUR ADDITIONAL RETESTS WERE PERFORMED, WHICH RESULTED IN 3 NOT DETECTED RESULTS AND ONE RESULT OF R132G DETECTED. CUSTOMER CONFIRMED THAT THE REPORTING RESULTS ARE ASSOCIATED WITH PATIENT MANAGEMENT. CUSTOMER IS RUNNING WHOLE BLOOD SAMPLES. CONTROLS WERE WITHIN RANGE; GLOBAL SERVICE AND SUPPORT, RESEARCH AND DEVELOPMENT AND TECHNICAL PRODUCT SPECIALIST HAVE REVIEWED THE LOG FILES. PER THE CUSTOMER, ELUATES WERE STORED PROPERLY ACCORDING THE IDH1 PACKAGE INSERT. THERE HAS NOT BEEN AN ALLEGATION OF ADVERSE IMPACT TO PATIENT MANAGEMENT. THE CUSTOMER STATED THAT HE HAD A FOLLOW UP CONVERSATION WITH THE TREATING PHYSICIAN. THE TREATING PHYSICIAN HAS BOTH MUTATIONS (R132C AND R132G) AS PART OF THE PATI

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9613389 ↗