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 2018-08-29 for GGT-2 ?-GLUTAMYLTRANSFERASE VER.2 - STANDARDIZED AGAINST SZASZ 03002721122 manufactured by Roche Diagnostics.
[119112830]
The event occurred in: (b)(6).
Patient Sequence No: 1, Text Type: N, H10
[119112831]
The customer originally complained about questionable crep2 creatinine plus ver. 2 tested on both a cobas 6000 c (501) module and a cobas 8000 (unspecified module) compared to an abbott system. From the data provided, a reportable malfunction was provided for crep2, astlp aspartate aminotransferase acc. To ifcc with pyridoxal phosphate activation, altlp alanine aminotransferase acc. To ifcc with pyridoxal phosphate activation, and ggt-2 -glutamyltransferase ver. 2 standardized against ifcc / szasz. This medwatch will cover ggt-2. Please refer to the medwatch with (b)(6) for information on astlp. Please refer to the medwatch with (b)(6) for information on crep2. Please refer to the medwatch with (b)(6) for information on altlp. The erroneous results were released outside of the laboratory. The patient was sent to the hospital due to the initial high crep2 result, but there was no allegation that the patient was adversely affected. The cobas c501 serial (b)(4). The customer did not provide any specific information on the cobas 8000 system. A preliminary assessment of the case stated that based on previous electrophoresis testing of the patient, the patient is believed to have an interfering factor present. The investigation is currently ongoing.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1823260-2018-02915 |
| MDR Report Key | 7827934 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2018-08-29 |
| Date of Report | 2018-10-08 |
| Date of Event | 2018-08-09 |
| Date Mfgr Received | 2018-08-10 |
| Date Added to Maude | 2018-08-29 |
| 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 | GGT-2 ?-GLUTAMYLTRANSFERASE VER.2 - STANDARDIZED AGAINST SZASZ |
| Generic Name | GAMMA-GLUTAMYL TRANSPEPTIDASE AND ISOENZYMES TEST SYSTEM |
| Product Code | JQB |
| Date Received | 2018-08-29 |
| Model Number | NA |
| Catalog Number | 03002721122 |
| Lot Number | ASKU |
| 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 | 2018-08-29 |