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 2017-02-13 for ELECSYS MYOGLOBIN IMMUNOASSAY 12178214160 manufactured by Roche Diagnostics.
[67339259]
Expiration date was provided as (b)(6) 2017. This event occurred in (b)(6). (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[67339260]
The customer questioned high results for 1 patient tested for elecsys myoglobin immunoassay (myoglobin) on a cobas 8000 e 602 module that did not fit the clinical picture for this patient. The patient was hospitalized due to kidney failure. The patient? S myoglobin results for more than 2 weeks were >3000 ug/l. The customer inquired if there is an interference with the myoglobin assay and the medications the patient is being treated with. Refer to attached data for the patient results. No adverse event occurred. The e602 module serial number was (b)(4). A specific root cause could not be identified for this event. Additional information was requested for investigation but was not provided. Since the patient has kidney failure, myoglobin results could be elevated due to the disease. It is also possible that the medications the patient is being treated with are having a cardio toxic effect increasing the myoglobin results. However, since no patient samples could be provided, this could not be confirmed.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1823260-2017-00299 |
| MDR Report Key | 6326819 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2017-02-13 |
| Date of Report | 2017-02-13 |
| Date of Event | 2016-12-31 |
| Date Mfgr Received | 2017-01-25 |
| Date Added to Maude | 2017-02-13 |
| 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 | ELECSYS MYOGLOBIN IMMUNOASSAY |
| Generic Name | MYOGLOBIN IMMUNOLOGICAL TEST SYSTEM |
| Product Code | DDR |
| Date Received | 2017-02-13 |
| Model Number | NA |
| Catalog Number | 12178214160 |
| Lot Number | 133148-01 |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| 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 | 2017-02-13 |