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 2016-09-22 for UREA/BUN 04460715190 manufactured by Roche Diagnostics.
[55451659]
Patient Sequence No: 1, Text Type: N, H10
[55451660]
The customer received questionable high ureal urea/bun patient results from cobas c501 serial number (b)(4) when they started using a new lot number of reagent. They calibrated the reagent pack and ran qc, but it was out of range high. After several attempts, they loaded a new reagent pack of the same lot, calibrated, and qc was then ok. They tested one patient on this analyzer and on another cobas c501 analyzer and it was good so they started running patient samples. The customer then noticed three patient results that were high when compared to the other cobas c501. Of the data provided, the results for two samples were discrepant. Sample 1 original estimated result was 50 mg/dl and the result on the other analyzer was 25 mg/dl. Sample 2 original result was 120 mg/dl with a data flag, the automatic repeat result with a dilution was 123 mg/dl. The repeat result on the other analyzer was 60 mg/dl. The erroneous results were reported outside the laboratory. The repeat results from the other analyzer were believed to be correct. The patients were not adversely affected. The field service representative found the cause was the bun reagent cassette. Upon his arrival onsite, the customer informed him that she had replaced the cassette. Bun samples were then running fine and comparing with other c501 analyzer. The tech performed precision testing which looked good. The calibration was good and qc was within the specifications. Further investigation confirmed the issue was resolved by using a new reagent cassette. Contamination of the affected cassette was assumed to be the root cause of this issue.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1823260-2016-01433 |
| MDR Report Key | 5969573 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2016-09-22 |
| Date of Report | 2016-09-22 |
| Date of Event | 2016-09-08 |
| Date Mfgr Received | 2016-09-09 |
| Date Added to Maude | 2016-09-22 |
| 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 |
| 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 | UREA/BUN |
| Generic Name | UREASE AND GLUTAMIC DEHYDROGENASE, UREA NITROGEN |
| Product Code | CDQ |
| Date Received | 2016-09-22 |
| Model Number | NA |
| Catalog Number | 04460715190 |
| Lot Number | 15958901 |
| ID Number | NA |
| Device Expiration Date | 2017-02-28 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| 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 | 2016-09-22 |