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 2018-07-17 for CREJ2 CREATININE JAFF? GEN.2 06407137190 manufactured by Roche Diagnostics.
[114713403]
The event occurred in: (b)(6).
Patient Sequence No: 1, Text Type: N, H10
[114713404]
The customer complained of questionable crej2 creatinine jaff? Gen. 2 control and patient results tested on a cobas 8000 c702 module. The customer stated that there is about a 25% difference in the initial patient and control results compared to when the same samples are retested. Specific patient results were requested but were not provided. The customer stated that this issue occurs sometimes when the reagent pack is almost empty. The results are again acceptable after performing a new calibration. The erroneous results were released outside of the laboratory, but no treatment was provided based on the erroneous results. There was no allegation of an adverse event. The cobas c702 serial number was (b)(4). A field engineering specialist changed the reagent probes, adjusted the reagent probes, and readjusted the cells. The customer stated they believed the carbon dioxide levels in the laboratory were acceptable. On (b)(6) 2018 the customer reported the issue was still ongoing. No specific details provided. The investigation is currently ongoing.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1823260-2018-02372 |
| MDR Report Key | 7695280 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2018-07-17 |
| Date of Report | 2018-09-17 |
| Date of Event | 2018-07-03 |
| Date Mfgr Received | 2018-07-03 |
| Date Added to Maude | 2018-07-17 |
| 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 | 2018-07-17 |
| Model Number | NA |
| Catalog Number | 06407137190 |
| Lot Number | ASKU |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| 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 | 2018-07-17 |