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 2018-05-29 for MYOGLOBIN 12178214122 manufactured by Roche Diagnostics.
[109902294]
This event occurred in (b)(6). Unique identifier (udi)#: (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[109902295]
The customer stated that they received erroneous results for one patient sample tested for the elecsys myoglobin immunoassay (myo) on an unknown roche analyzer. No erroneous results were reported outside of the laboratory. The sample initially resulted as 1300 ng/ml. The sample was diluted manually x11 and then repeated with a x100 automatic dilution, resulting with a final value of 289000 ng/ml. The sample was also diluted manually x21 and then repeated with a x100 automatic dilution, resulting with a final value of 350000 ng/ml. No adverse events were alleged to have occurred with the patient. The model and serial number of the roche analyzer were asked for, but not provided. It was suspected that the sample exhibited a prozone effect since the myo value exceeds 30000 ng/ml. Product labeling indicates that there is no high-dose hook effect at myoglobin concentrations up to 30000 ng/ml. No foam or clots were visible within the sample.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1823260-2018-01618 |
| MDR Report Key | 7548542 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2018-05-29 |
| Date of Report | 2018-06-21 |
| Date of Event | 2018-05-09 |
| Date Mfgr Received | 2018-05-09 |
| Date Added to Maude | 2018-05-29 |
| 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 | MYOGLOBIN |
| Generic Name | MYOGLOBIN IMMUNOLOGICAL TEST SYSTEM |
| Product Code | DDR |
| Date Received | 2018-05-29 |
| Model Number | NA |
| Catalog Number | 12178214122 |
| 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 | 2018-05-29 |