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 2017-06-02 for ASTL ASPARTATE AMINOTRANSFERASE - PYRIDOXAL PHOSPHATE ACTIVATED manufactured by Roche Diagnostics.
[76519374]
(b)(6). (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[76519375]
The customer states that a physician complained about fluctuating sample values for 5 samples from the same patient tested for astl aspartate aminotransferase acc. To ifcc without pyridoxal phosphate activation (ast) and altl alanine aminotransferase acc. To ifcc without pyridoxal phosphate activation (alt) on a cobas 6000 c (501) module - c501. All results were reported outside of the laboratory. This medwatch will apply to ast. Please refer to the medwatch with (b)(6) for information related to alt. The physician believed the results to be too different when compared from day to day. No adverse events were alleged to have occurred to the patient. The c501 analyzer serial number was (b)(4).
Patient Sequence No: 1, Text Type: D, B5
[78489340]
The issue occurred only with one patient and all other tests run on the patient's samples were not affected. A specific root cause could not be determined based on the available information. Additional information required for the investigation was requested but not provided. Fluctuating interferences in connection with the alt and ast assays are not known. It is possible that an issue with pre-analytic handling occurred. Based upon medical assessment, highly varying ast and alt values can be caused by disease such as sepsis. Day to day variation of aminotransferases with this patient condition can be 10 - 30 %. Controls began to drift down and exhibit imprecision on (b)(6) 2017, but controls were still within range. Based on calibration and control results being within range and precision studies, an issue with the reagent or hardware can be excluded.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1823260-2017-01129 |
| MDR Report Key | 6607475 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2017-06-02 |
| Date of Report | 2017-06-27 |
| Date of Event | 2017-05-06 |
| Date Mfgr Received | 2017-05-16 |
| Date Added to Maude | 2017-06-02 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| 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 | ASTL ASPARTATE AMINOTRANSFERASE - PYRIDOXAL PHOSPHATE ACTIVATED |
| Generic Name | NADH OXIDATION/NAD REDUCTION, AST/SGOT |
| Product Code | CIT |
| Date Received | 2017-06-02 |
| Model Number | NA |
| Catalog Number | ASKU |
| Lot Number | 195496 |
| 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 | 2017-06-02 |