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 2015-09-17 for COBAS INTEGRA C-REACTIVE PROTEIN LATEX 20764930322 manufactured by Roche Diagnostics.
[26113151]
This event occurred in (b)(6).
Patient Sequence No: 1, Text Type: N, H10
[26113152]
The customer received a questionable c-reactive protein (crp) result for one patient sample from integra 400 analyzer serial number (b)(4). The results were all between 46 and 54 mg/dl. A specific result of 46. 42 mg/dl was provided. The system automatically diluted the sample 1:10, and the high value could be confirmed. Results of 49. 896 mg/dl and 59. 925 mg/dl were provided, but it was unclear if these results were generated with a dilution. The result of 46. 42 mg/dl was reported outside the laboratory. The physician did not believe the result. An aliquot of the same sample was tested on a cobas c501 and the result was 8. 061 mg/dl and could be confirmed. This value was believed by the physician. On (b)(6) 2015, the same sample was tested on the integra again. The high result was again confirmed. Information concerning if the patient was adversely affected was requested, but was not provided.
Patient Sequence No: 1, Text Type: D, B5
[27147899]
Additional information was received that the field service representative checked the system. He replaced the probes, adjusted the wash station and exchanged the photometer lamp these issues could have been a cause of the event.
Patient Sequence No: 1, Text Type: N, H10
[31397663]
A specific root cause could not be identified. Sample from the patient was submitted for investigation. Based on the results and review of the reaction kinetics, some kind of interference in the sample was suspected.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1823260-2015-04185 |
| MDR Report Key | 5085005 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2015-09-17 |
| Date of Report | 2015-10-27 |
| Date of Event | 2015-09-03 |
| Date Mfgr Received | 2015-09-04 |
| Date Added to Maude | 2015-09-17 |
| 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 |
| 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 | COBAS INTEGRA C-REACTIVE PROTEIN LATEX |
| Generic Name | C-REACTIVE PROTEIN |
| Product Code | DCN |
| Date Received | 2015-09-17 |
| Model Number | NA |
| Catalog Number | 20764930322 |
| Lot Number | 618082 |
| ID Number | NA |
| 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 46250 US 46250 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-09-17 |