MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2011-06-06 for MYOGLOBIN STAT (SHORT TURN AROUND TIME) (MYOGLOBIN STAT) 11820788160 manufactured by Roche Diagnostics.
[1971665]
The user received a questionable myoglobin result for one patient sample from the elecsys 2010 disk analyzer (b)(4). The initial result was 1244 ng/ml and was reported outside the laboratory. The sample was repeated due to the patient's history and the repeat results were 100. 6 ng/ml and 88 ng/ml. Additional repeat testing was performed on the sample. The specific results were not provided, but the user stated they recovered similarly to the first repeat result. The patient was not adversely affected. Upon evaluation of the analyzer, the field service representative determined the bead mixer was rotating too fast and the probe was adjusted too high. He adjusted the bead mixer speed and the probe height. To verify the analyzer operation, he ran performance testing and precision tests which passed. The user ran quality control with results within their acceptable range.
Patient Sequence No: 1, Text Type: D, B5
[9130450]
It was unknown if the initial reporter sent report to the fda.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1823260-2011-03045 |
| MDR Report Key | 2114721 |
| Report Source | 05,06 |
| Date Received | 2011-06-06 |
| Date of Report | 2011-06-06 |
| Date of Event | 2011-05-19 |
| Date Mfgr Received | 2011-05-21 |
| Date Added to Maude | 2011-06-06 |
| 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 | 0 |
| Event Location | 3 |
| Manufacturer Contact | NA RAE ANN FARROW |
| Manufacturer Street | 9115 HAGUE ROAD NA |
| Manufacturer City | INDIANAPOLIS IN 46250 |
| Manufacturer Country | US |
| Manufacturer Postal | 46250 |
| Manufacturer Phone | 3175213194 |
| Manufacturer G1 | ROCHE DIAGNOSTICS GMBH |
| Manufacturer Street | SANDHOFERSTRASSE 118 NA |
| Manufacturer City | MANNHEIM (BADEN-WURTTEMBERG) 68300 |
| Manufacturer Postal Code | 68300 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MYOGLOBIN STAT (SHORT TURN AROUND TIME) (MYOGLOBIN STAT) |
| Generic Name | MYOGLOBIN, ANTIGEN, ANTISERUM, CONTROL |
| Product Code | DDR |
| Date Received | 2011-06-06 |
| Model Number | NA |
| Catalog Number | 11820788160 |
| Lot Number | 16083102 |
| ID Number | NA |
| Device Expiration Date | 2012-05-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ROCHE DIAGNOSTICS |
| Manufacturer Address | 9118 HAGUE ROAD NA INDIANAPOLIS IN 46250 US 46250 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-06-06 |