MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,u report with the FDA on 2017-09-14 for ACETAMINOPHEN 20767174322 manufactured by Roche Diagnostics.
[86702094]
Unique identifier (udi)#:(b)(4). This event occurred in (b)(6).
Patient Sequence No: 1, Text Type: N, H10
[86702095]
The customer received a questionable high aceta acetaminophen result for one patient sample from a cobas 6000 c (501) module. The patient was hospitalized due to suspicion of intoxication with redomex (amitripyline). For a sample taken at 4:30 pm, the result was 32. 1 mg/l and was reported outside the laboratory. This sample had a hemolysis index of 909. A urine toxicology screening (triage) was performed and the results were negative for paracetamol. Refer to the attachment to the medwatch for all toxicology screen results. The doctors decided to treat the patient with acetylcysteine as the first acetaminophen result was above >30 mg/l. A new sample was taken at 5:20 pm. This sample was not hemolytic and the acetaminophen result was repeatedly less than the measuring range of the assay. The results were -0. 8, -0. 4, and -0. 2 mg/l with data flags. The first sample was repeated on (b)(6) 2017 with reagent lot 205114 and the result was 24. 0 mg/l. A third sample was drawn and tested on (b)(6) 2017 and the acetaminophen result -0. 1 mg/l with a data flag. There was no allegation of an adverse event. Investigation of the issue found the high results were likely due to the hemolysis. As the assay is colorimetric, a very high hemolysis index can lead to false positive results as the hemolytic sample disturbs the absorbance of the assay. Product labeling for the assay states at a hemolysis index >150, the interference can be +/-10%. Review of the reaction kinetics for all samples from the patient showed an unusual increase in absorbance before the r2 reagent was added. The kinetics of the samples with low results showed a high scattering of the absorbance signals. This may be due to a disturbance in the reaction due to patient's clinical picture such as a gammopathy or an instrument issue. The customer had two cobas 6000 c (501) modules, but was not sure which was used for the testing. The serial numbers were requested but were not provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1823260-2017-01982 |
| MDR Report Key | 6864432 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2017-09-14 |
| Date of Report | 2017-09-28 |
| Date of Event | 2017-07-27 |
| Date Mfgr Received | 2017-08-25 |
| Date Added to Maude | 2017-09-14 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | NA MICHAEL LESLIE |
| Manufacturer Street | 9115 HAGUE ROAD NA |
| Manufacturer City | INDIANAPOLIS IN 46250 |
| Manufacturer Country | US |
| Manufacturer Postal | 46250 |
| Manufacturer Phone | 3175214343 |
| Manufacturer G1 | ROCHE DIAGNOSTICS GMBH |
| Manufacturer Street | SANDHOFERSTRASSE 116 NA |
| Manufacturer City | MANNHEIM (BADEN-WURTTEMBERG) 68305 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 68305 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ACETAMINOPHEN |
| Generic Name | COLORIMETRY, ACETAMINOPHEN |
| Product Code | LDP |
| Date Received | 2017-09-14 |
| Model Number | NA |
| Catalog Number | 20767174322 |
| Lot Number | 172208 |
| ID Number | NA |
| 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 ROAD NA INDIANAPOLIS IN 462500457 US 462500457 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-09-14 |