MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2017-12-19 for CREJ2 CREATININE JAFF? GEN.2 - COMPENSATED METHOD FOR SERUM AND PLASMA 04810716190 manufactured by Roche Diagnostics.
[95910908]
(b)(4).
Patient Sequence No: 1, Text Type: N, H10
[95910909]
The customer stated that they received questionable results for a total of 4 patient samples tested for bilt3 bilirubin total gen. 3 (tbil) and crej2 creatinine jaff? Gen. 2 (creat) on a cobas 6000 c (501) module - c501 between (b)(6) 2017 and (b)(6) 2017. The results for all samples were initially low and repeated higher. Of the four samples, one had an erroneous result for creat. It was asked, but it is not known if the erroneous result was reported outside of the laboratory. The specific date of event was not provided for this complained sample. The sample was tested either on (b)(6) 2017 or (b)(6) 2017. The sample initially resulted as < 0. 0 mg/dl and repeated as 1. 0 mg/dl. The repeat value was believed to be correct. The patient was not adversely affected. (b)(4). The field service engineer determined that the issue was caused by a failure of the reagent pack. He replaced the reagent pack and replaced the sample probe as a preventive measure. The customer ran calibrations and quality controls; these were within laboratory guidelines. A precision study was performed and recovery was within guidelines.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1823260-2017-03004 |
| MDR Report Key | 7128762 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2017-12-19 |
| Date of Report | 2018-03-05 |
| Date of Event | 2017-11-29 |
| Date Mfgr Received | 2017-11-30 |
| Date Added to Maude | 2017-12-19 |
| 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 | MEDICAL TECHNOLOGIST |
| 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 - COMPENSATED METHOD FOR SERUM AND PLASMA |
| Generic Name | ALKALINE PICRATE, COLORIMETRY, CREATININE |
| Product Code | CGX |
| Date Received | 2017-12-19 |
| Model Number | NA |
| Catalog Number | 04810716190 |
| Lot Number | ASKU |
| ID Number | NA |
| 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 | 2017-12-19 |