MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2011-07-26 for CREATINE KINASE 04524977190 manufactured by Roche Diagnostics.
[19201309]
The customer received a questionable ck result from their cobas c501 (serial number (b)(4)). There was one discrepant result which was reported outside the laboratory. The physician questioned the result because the ck result was lower than the ck-mb result. The sample was re-tested on the same analyzer. The patient's initial ck result was 13 u/l. The first repeat result was 3515 u/l accompanied by a data flag. The sample was diluted and repeated. The second repeat result was 3885 u/l. The customer believes 3885 u/l was the correct result and it was issued as a corrected report. The patient was not treated based on the erroneous result and there were no adverse affects from this event. The field service representative determined the cause of the event was a sample probe contaminated with gel from the tube. He replaced the sample probe and checked the probe alignment. Diagnostic checks were performed. A precision test was performed with passing results.
Patient Sequence No: 1, Text Type: D, B5
[19449419]
.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1823260-2011-03982 |
| MDR Report Key | 2176437 |
| Report Source | 05,06 |
| Date Received | 2011-07-26 |
| Date of Report | 2011-07-21 |
| Date of Event | 2011-07-11 |
| Date Mfgr Received | 2011-07-12 |
| Date Added to Maude | 2011-07-26 |
| 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 |
| Reporter Occupation | MEDICAL TECHNOLOGIST |
| 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 | CREATINE KINASE |
| Generic Name | DIFFERENTIAL RATE KINETIC METHOD, CPK OR ISOENZYMES |
| Product Code | JHS |
| Date Received | 2011-07-26 |
| Model Number | NA |
| Catalog Number | 04524977190 |
| Lot Number | 63885801 |
| ID Number | NA |
| Device Expiration Date | 2012-02-29 |
| Operator | MEDICAL TECHNOLOGIST |
| 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 | 2011-07-26 |