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 2015-10-19 for CREATINE KINASE 04524977190 manufactured by Roche Diagnostics.
[28675583]
This event occurred in (b)(6).
Patient Sequence No: 1, Text Type: N, H10
[28675584]
The customer received questionable creatine kinase results for one patient sample from two cobas c501 analyzers. The initial result from cobas c501 serial number (b)(4) was 692. 6 u/l with a data flag. The repeat testing gave no numeric result but a data flag. The sample was repeated on cobas c501 serial number (b)(4) and the result was 296. 4 u/l which was reported outside the laboratory. Later in the day, a repeat sample was received for the patient and the customer decided to repeat the original sample. The sample was repeated on cobas c501 serial number (b)(4) and the results were 341 u/l with a data flag and no numeric result but a data flag. The sample was repeated on cobas c501 serial number (b)(4) and the results were 485. 3 u/l with a data flag and no numeric result but a data flag. With a 1:20 dilution, the results in sample cups were 35748 u/l and 29164 u/l. The results with the dilution were believed to be correct and a corrected report was issued. The patient was not adversely affected.
Patient Sequence No: 1, Text Type: D, B5
[33614044]
A specific root cause could not be identified. Based on the provided calibration, qc, and precision data, the instruments were working according to specifications. As only one sample was affected, the issue seems to be a preanalytic sample issue.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1823260-2015-04354 |
| MDR Report Key | 5160115 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2015-10-19 |
| Date of Report | 2015-12-16 |
| Date of Event | 2015-09-18 |
| Date Mfgr Received | 2015-10-01 |
| Date Added to Maude | 2015-10-19 |
| 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 | CREATINE KINASE |
| Generic Name | DIFFERENTIAL RATE KINETIC METHOD, CPK OR ISOENZYMES |
| Product Code | JHS |
| Date Received | 2015-10-19 |
| Model Number | NA |
| Catalog Number | 04524977190 |
| Lot Number | 66033801 |
| 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 | 2015-10-19 |