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 2017-01-04 for MYO2 TINA-QUANT MYOGLOBIN GEN.2 04580010190 manufactured by Roche Diagnostics.
[63826856]
This event occurred in (b)(6). (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[63826857]
The customer is questioning the results from 15 patient samples tested for myo2 tina-quant myoglobin gen. 2 (myo2) on a cobas 6000 c (501) module compared to elecsys myoglobin immunoassay (myoglobin) results on a cobas e 411 immunoassay analyzer. Based on the data provided, the results for 5 patient samples were erroneous. It is not known if the comparison results were being used for diagnostic purposes. It is not known which results were believed to be correct. This information has been requested. The results from the e411 analyzer were not reported outside of the laboratory. It is not known if the results from the c501 were reported outside of the laboratory. No adverse event occurred. The c501 module serial number was not provided. The e411 analyzer serial number (b)(4).
Patient Sequence No: 1, Text Type: D, B5
[65685571]
A specific root cause could not be identified. Additional information was requested for investigation but was not provided. Since no patient samples were available, the investigation could not be completed. No issues were identified during troubleshooting at the customer site.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1823260-2017-00008 |
| MDR Report Key | 6221323 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2017-01-04 |
| Date of Report | 2017-01-24 |
| Date of Event | 2016-12-07 |
| Date Mfgr Received | 2016-12-09 |
| Date Added to Maude | 2017-01-04 |
| 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 | MYO2 TINA-QUANT MYOGLOBIN GEN.2 |
| Generic Name | MYOGLOBIN IMMUNOLOGICAL TEST SYSTEM |
| Product Code | DDR |
| Date Received | 2017-01-04 |
| Model Number | NA |
| Catalog Number | 04580010190 |
| 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 462500457 US 462500457 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-01-04 |