MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2011-07-24 for CARDIAC C-REACTIVE PROTEIN 11972855216 manufactured by Roche Diagnostics.
[2109076]
The customer had an intermittent issue with erratic results for multiple assays when tested on an analytical p module, serial number (b)(4). Eighteen patients were involved in the issue. The assays included creatinine kinase, creatinine, c-reactive protein, alanine aminotransferase, aspartate aminotransferase, and potassium. Most of the initial results did not match the patient's previous results and were not reported outside the laboratory. The customer did provide erroneous c-reactive protein results for one patient that was reported outside the laboratory. The initial c-reactive protein result was tested on (b)(6) 2011 and recovered 3. 566 mg/dl (accompanied by a data flag). The sample was repeated, using the same analyzer, on (b)(6) 2011 and recovered 7. 7 mg/dl. This result was reported outside the laboratory. The sample was repeated again, using the same analyzer, on (b)(6) 2011 and recovered 0. 373 mg/dl (accompanied by a data flag). The sample was repeated a final time on (b)(6) 2011, using the same analyzer, and recovered 26. 216 mg/dl. A corrected report was sent on (b)(6) 2011 with the 26. 2 mg/dl result. The patient was not adversely affected because of erroneous results having been reported. The field service representative determined a clogged water nozzle tube was the cause of the discrepancies and he cleaned the tubing. The field service representative verified analyzer operation and the customer ran calibrations and quality control that were acceptable to the customer.
Patient Sequence No: 1, Text Type: D, B5
[9254885]
.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1823260-2011-03944 |
| MDR Report Key | 2174434 |
| Report Source | 05,06 |
| Date Received | 2011-07-24 |
| Date of Report | 2011-07-20 |
| Date of Event | 2011-06-29 |
| Date Mfgr Received | 2011-07-01 |
| Date Added to Maude | 2011-07-24 |
| 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) 68305 |
| Manufacturer Postal Code | 68305 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CARDIAC C-REACTIVE PROTEIN |
| Generic Name | TINA-QUANT CRP (LATEX) HS TEST SYSTEM |
| Product Code | NQD |
| Date Received | 2011-07-24 |
| Model Number | NA |
| Catalog Number | 11972855216 |
| Lot Number | 63922201 |
| ID Number | NA |
| Device Expiration Date | 2012-03-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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 | 2011-07-24 |