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 2012-09-14 for COBAS C (111) CRP LX 200T 05401615190 manufactured by Roche Diagnostics.
[2880146]
The customer alleged they received questionable c-reactive protein (latex) (crp) results on their cobas c111 analyzer, serial number (b)(4), starting on (b)(6) 2012. The customer provided data for five samples with discrepant results that were reported outside the laboratory. The customer noted the issue was occurring when there were about 20 tests left in the reagent bottle. The customer inverted the latex reagent several times before use and used the recommended chimneys in the reagent bottle. The customer checked there was no foam on top of the reagent. The first patient's initial crp test came back with a kin read error message. The sample was repeated with dilution and the result was 33 mg/l. The sample was then tested on a cobas c311 analyzer, serial number not provided, and the result was 292 mg/l. The sample was then tested on a point of case meter and the result was >200 mg/l. The sample was then retested on the c111 analyzer and the result was 5. 9 mg/l. The customer then switched to a new bottle of crp reagent and the result from the c111 analyzer was 278 mg/l. After the initial sample's discrepant results, the customer decided to repeat all the other crp tests using the new bottle of crp reagent. The second patient's initial crp result was 0. 23 mg/l. The repeat result was 16 mg/l. The third patient's initial crp result was 0. 84 mg/l. The repeat result was 37 mg/l. The fourth patient's initial crp result was 72 mg/l. The repeat result was 44 mg/l. The fifth patient's initial crp result was 110 mg/l. The repeat result was 80 mg/l. It was unknown if there were any adverse events.
Patient Sequence No: 1, Text Type: D, B5
[10177261]
It was unknown if the initial reporter sent report to the fda. This event occurred in (b)(6).
Patient Sequence No: 1, Text Type: N, H10
[10376771]
This event occurred in finland. During the investigation of the event, 30 humans samples were tested using the crp reagent on a cobas c111 analyzer to determine if there were different results when the reagent bottle is full, at 100 tests, and the bottle is nearly empty, at 30 tests. The method comparison was well within specification, with a slope of 1. 003. Upon further investigation of this event, the customer stated someone in their laboratory began to wash the chimneys that are placed in the reagent bottles. Washing the chimney can lead to a situation where detergent residuals of the cleaning agent are brought into the reagent. While the package insert for the reagent states the chimneys can be reused for reagent bottles within the same kit , it does not instruct the customers to wash the chimneys. No patients were hospitalized due to the results and no one was reported to suffer from adverse events.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1823260-2012-04598 |
| MDR Report Key | 2745301 |
| Report Source | 01,05,06 |
| Date Received | 2012-09-14 |
| Date of Report | 2012-10-19 |
| Date of Event | 2012-09-06 |
| Date Mfgr Received | 2012-09-06 |
| Date Added to Maude | 2012-09-14 |
| 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 JENNIFER WOLFGRAM |
| Manufacturer Street | 9115 HAGUE ROAD NA |
| Manufacturer City | INDIANAPOLIS IN 46250 |
| Manufacturer Country | US |
| Manufacturer Postal | 46250 |
| Manufacturer Phone | 3175217008 |
| Manufacturer G1 | ROCHE DIAGNOSTICS GMBH |
| Manufacturer Street | SANDHOFERSTRASSE 116 NA |
| Manufacturer City | MANNHEIM (BADEN-WURTTEMBERG) 312-8504 |
| Manufacturer Postal Code | 312-8504 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | COBAS C (111) CRP LX 200T |
| Generic Name | SYSTEM, TEST, C-REACTIVE PROTEIN |
| Product Code | DCN |
| Date Received | 2012-09-14 |
| Model Number | NA |
| Catalog Number | 05401615190 |
| Lot Number | NA |
| ID Number | NA |
| Device Expiration Date | 2014-02-27 |
| 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 | 2012-09-14 |