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 2015-10-01 for CK-MB - THE MB ISOENZYME OF CREATINE KINASE manufactured by Roche Diagnostics.
[27204300]
This event occurred in (b)(6). A patient (b)(6) was also provided. A clarification has been requested. (b)(6) was also provided.
Patient Sequence No: 1, Text Type: N, H10
[27204301]
The customer reported that the values of the troponin t hs (high sensitive) stat (short turn around time) - tnt test were too high in contrast to the clinical status of one patient. The patient was subjected to an electric shock, but is currently in good condition. The patient's ecg was normal, the blood pressure was normal, and other clinical signs were also ok. The ck-mb - the mb isoenzyme of creatine kinase (ckmb) test results of the patient were also said to be elevated. The test results were measured on an e601 analyzer. The patient's samples were suspected of containing an interference to the assays. This medwatch will cover ckmb. Please refer to the medwatch with (b)(6) for information related to the tnt assay. The tnt assay was measured 4 times upon admission of the patient, on (b)(6) 2015. The values were said to be "between 41 to 48" ng/l. The ckmb results of the patient were also said to be increased upon admission, with a values of 12. 1 ug/l on (b)(6) 2015. The ckmb values then decreased to 5. 5 ug/l on (b)(6) 2015. The n-terminal pro b-type natriuretic peptide (bnp) was said to be slightly elevated on (b)(6) 2015, with a value of 135 pg/ml. The patient was hospitalized for six days for observation in the icu based on the tnt and ckmb results, but was not adversely affected. The e601 analyzer serial number was (b)(4). Preliminary investigations have determined that an electrical shock is an event that is expected to have an impact on cardiac tissue. Therefore, elevated cardiac markers should be expected, too.
Patient Sequence No: 1, Text Type: D, B5
[28343666]
A sample from the patient was provided for investigation and the customer's results could be confirmed. The date of birth on medwatch field a2 has been updated.
Patient Sequence No: 1, Text Type: N, H10
[30737935]
A specific root cause for the difference in ck-mb values could not be determined based on the provided information.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1823260-2015-04257 |
| MDR Report Key | 5116171 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2015-10-01 |
| Date of Report | 2015-11-09 |
| Date of Event | 2015-08-12 |
| Date Mfgr Received | 2015-09-08 |
| Date Added to Maude | 2015-10-01 |
| 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 | CK-MB - THE MB ISOENZYME OF CREATINE KINASE |
| Generic Name | COLORIMETRIC METHOD, CPK OR ISOENZYMES |
| Product Code | JHY |
| Date Received | 2015-10-01 |
| Model Number | NA |
| Catalog Number | ASKU |
| Lot Number | ASKU |
| 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 | 2015-10-01 |