MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a * report with the FDA on 2010-08-30 for ROCHE ACETAMINOPHEN 03255379190 manufactured by Roche Diagnostics.
[1353877]
The customer alleged a significant bilirubin interference with the (b)(4) acetaminophen application. The customer received a questionable result for acetaminophen on the analytical p module for one patient sample collected from a transplant patient. The date of occurrence was not provided. The initial result for acetaminophen was 130 umol/l. This result was reported outside the laboratory. The bilirubin concentration for this sample was about 300 umol/l. A urine sample obtained from the patient was tested by (b)(6) and no acetaminophen was detected in this urine sample. The patient was treated with (nac) n-acetyl cysteine due to the questionable acetaminophen result of 130 umol/l. No adverse event has been alleged reagarding this event. The acetaminophen reagent lot number was not provided.
Patient Sequence No: 1, Text Type: D, B5
[1830785]
Patient Sequence No: 1, Text Type: D, B5
[8780339]
The event occurred in (b)(6).
Patient Sequence No: 1, Text Type: N, H10
[8875229]
An urgent medical device correction was issued containing the following information: the "limitations - interference" section of the acetaminophen package insert, e-package insert, and method sheets will be updated to more clearly indicate the impact of icteric, hemolytic, or lipemic samples with low levels of acetaminophen. The updated acetaminophen labeling (i. E. , package insert, e-package insert, and method sheets) will be made available as soon as possible. False positive acetaminophen results may be obtained for acetaminophen- free samples if an endogenous interferent (i. E. , bilirubin, hemolysis, or lipemia) is present. This may cause n-acetylcysteine treatment to be unnecessarily initiated in patients with elevated bilirubin concentrations. Since most of the patients seen within the first 24 hours of an acute acetaminophen overdose present with only slightly increased bilirubin concentrations, it is unlikely that false positive acetaminophen results will occur in the setting of acute acetaminophen toxicity. In patients with acute liver injury, the false positive results may lead to the incorrect clinical interpretation that the injury is caused by acetaminophen ingestion. Endogenous interferents (i. E. , bilirubin, hemolysis, and/or lipemia) may produce a falsely elevated value for samples containing concentrations less than 50 ug/ml of acetaminophen.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1823260-2010-05159 |
| MDR Report Key | 1819493 |
| Report Source | * |
| Date Received | 2010-08-30 |
| Date of Report | 2010-12-22 |
| Date of Event | 2010-08-04 |
| Date Mfgr Received | 2010-08-04 |
| Date Added to Maude | 2010-12-22 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 3 |
| Manufacturer Contact | ERIC KOLODZIEJ |
| Manufacturer Street | 9115 HAGUE ROAD |
| Manufacturer City | INDIANAPOLIS IN 46250 |
| Manufacturer Country | US |
| Manufacturer Postal | 46250 |
| Manufacturer Phone | 3175212834 |
| Manufacturer G1 | ROCHE DIAGNOSTICS GMBH |
| Manufacturer Street | SANDHOFERSTRASSE 118 |
| Manufacturer City | MANNHEIM (BADEN-WURTTEMBERG) 68300 |
| Manufacturer Postal Code | 68300 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | 1823260-11/18/10-002-C |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ROCHE ACETAMINOPHEN |
| Generic Name | COLORIMETRY, ACETAMINOPHEN |
| Product Code | LDP |
| Date Received | 2010-08-30 |
| Catalog Number | 03255379190 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ROCHE DIAGNOSTICS |
| Manufacturer Address | 9115 HAGUE RD. INDIANAPOLIS IN 46250 US 46250 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2010-08-30 |