MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,06 report with the FDA on 2011-05-09 for C-REACTIVE PROTEIN (LATEX) 20764930322 manufactured by Roche Diagnostics.
[2027338]
The user received questionable c-reactive protein (crp) results for two samples from one patient on the cobas integra 400 plus analyzer serial number (b)(4) when compared to the results from the cobas c701 analyzer tested approximately three days later. Sample 1 result from the integra was 2936. 4 mg/l and the result from the cobas c701 was 2. 41 mg/l. On (b)(6) 2011, sample 2 result from the integra was 2918. 0 mg/l and the result from the cobas c701 was 18. 4 mg/l. No adverse events were alleged regarding the issue. The doctor stated the crp results from the cobas c701 reveal the correct values as the patient leucocytes and interleukin 6 results were within the normal range.
Patient Sequence No: 1, Text Type: D, B5
[9105482]
This event occurred in (b)(6).
Patient Sequence No: 1, Text Type: N, H10
[9275220]
The investigation confirmed the deviations in crp results between the analyzers. The crp reagent for the integra differs from the crp reagent for the cobas c701, which might be a reason for the observed difference in the results. During testing of the patient's samples, extremely elevated igm results and a kappa/lambda ratio outside the normal range were discovered. These results indicate a monoclonal gammopathy which is a documented limitation mentioned in product labeling for the assay. The turbidity principle of the crp latex agglutination test is strongly interfered with by other proteins in the sample, which may cause additional turbidities. Crp measurements will be repeated several times in symptomatic patients. Results should always be evaluated in context with the patient's clinical status and additional laboratory parameters such as leukocyte count, procalcitonin etc.
Patient Sequence No: 1, Text Type: N, H10
[9287835]
Additional information was received concerning the patient. The patient diagnoses were: "embolic ischemia, ineffective anticoagulation, hypertensive, diabetes mellitus type ii, colon resection. " the patient medications were: "digitoxin 0. 07 mg 1-0-0, delix 5 plus 1- 0-1, beloe zok 1-0-1, amlodipin 5 mg 1-0-1, atacand 32 mg 1-0-1, ebrantil 60 mg 1-0-1, janumet 50/1000 1-0-1, finamed 5 mg 0-0-1, simvastatin 40 mg 0-0-1, lantus 0-00-44, ie insulins rapid after bz sohema. "
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1823260-2011-02462 |
| MDR Report Key | 2081161 |
| Report Source | 01,05,06 |
| Date Received | 2011-05-09 |
| Date of Report | 2011-08-02 |
| Date of Event | 2011-04-06 |
| Date Mfgr Received | 2011-04-19 |
| Date Added to Maude | 2011-05-09 |
| 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 | 0 |
| Event Location | 3 |
| Manufacturer Contact | NA RAE ANN FARROW |
| Manufacturer Street | 9115 HAGUE ROAD NA |
| Manufacturer City | INDIANAPOLIS IN 46250 |
| Manufacturer Country | US |
| Manufacturer Postal | 46250 |
| Manufacturer Phone | 3175213194 |
| Manufacturer G1 | ROCHE DIAGNOSTICS GMBH |
| Manufacturer Street | SANDHOFERSTRASSE 118 NA |
| Manufacturer City | MANNHEIM (BADEN-WURTTEMBERG) 68300 |
| Manufacturer Postal Code | 68300 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | C-REACTIVE PROTEIN (LATEX) |
| Generic Name | SYSTEM, TEST, C-REACTIVE PROTEIN |
| Product Code | DCN |
| Date Received | 2011-05-09 |
| Model Number | NA |
| Catalog Number | 20764930322 |
| Lot Number | 639215 |
| ID Number | NA |
| Device Expiration Date | 2010-11-30 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ROCHE DIAGNOSTICS |
| Manufacturer Address | 9118 HAGUE ROAD NA INDIANAPOLIS NA NA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-05-09 |