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 2018-12-19 for CKL CREATINE KINASE manufactured by Roche Diagnostics.
[131155645]
(b)(6).
Patient Sequence No: 1, Text Type: N, H10
[131155646]
The customer consistently received questionable high troponin t hs, creatine kinase (ck), and elecsys ck-mb immunoassay results for one patient from the cobas 8000 cobas e 602 module serial number (b)(4). This medwatch is for creatine kinase. Refer to the "medwatchs" with patient identifiers (b)(6) and (b)(6) for the other assays. The doctor believed the result were an "implausible constellation of cardiac markers in case of a showing no cardiac symptoms". There was no evidence of an acute myocardial infarct. There was no allegation of an adverse event. The customer suspected a non-cardiac isoform of troponin t was present.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1823260-2018-05005 |
| MDR Report Key | 8178968 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2018-12-19 |
| Date of Report | 2019-02-15 |
| Date of Event | 2018-12-06 |
| Date Mfgr Received | 2018-12-07 |
| Date Added to Maude | 2018-12-19 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| 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 | CKL CREATINE KINASE |
| Generic Name | DIFFERENTIAL RATE KINETIC METHOD, CPK OR ISOENZYMES |
| Product Code | JHS |
| Date Received | 2018-12-19 |
| Model Number | NA |
| Catalog Number | ASKU |
| Lot Number | ASKU |
| 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 | 9115 HAGUE ROAD NA INDIANAPOLIS IN 462500457 US 462500457 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-12-19 |