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 2018-08-23 for CREJ2 CREATININE JAFF? GEN.2 06407137190 manufactured by Roche Diagnostics.
[118103131]
(b)(6).
Patient Sequence No: 1, Text Type: N, H10
[118103132]
The customer stated that they received erroneous results for 11 patient samples tested for crej2 creatinine jaff? Gen. 2 on a cobas 8000 c 702 module that were tested in sequence. The initial erroneous results were reported outside of the laboratory. The samples were repeated and the repeat results were not reported outside of the laboratory as the customer believed there was no clinical difference between the initial and repeat results. No adverse events were alleged to have occurred with the patients. The serial number of the c 702 analyzer is (b)(4). Upon visual inspection, all samples were clear and did not contain fibrin. The number of tests left in the reagent pack was low, so the field service representative changed the reagent pack, calibrated, and then ran controls. The customer measured controls every 4 hours to monitor the issue and no other issues have were noted. Calibration and controls were within expected ranges, however the customer repeated controls after the low patient values were noticed and controls had lower values similar to the affected patient values. Upon review of the alarm trace, some low water bath volume alarms were observed. There were also alarms indicating that the water reservoir level was too low and that there was an issue with a pump.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1823260-2018-02847 |
| MDR Report Key | 7810385 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2018-08-23 |
| Date of Report | 2018-10-09 |
| Date of Event | 2018-08-03 |
| Date Mfgr Received | 2018-08-07 |
| Date Added to Maude | 2018-08-23 |
| 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 | CREJ2 CREATININE JAFF? GEN.2 |
| Generic Name | ALKALINE PICRATE, COLORIMETRY, CREATININE |
| Product Code | CGX |
| Date Received | 2018-08-23 |
| Model Number | NA |
| Catalog Number | 06407137190 |
| Lot Number | 314035 |
| Device Expiration Date | 2019-10-31 |
| 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 | 2018-08-23 |