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 2018-05-18 for ETHANOL GEN.2 05967104190 manufactured by Roche Diagnostics.
[108640538]
This event occurred in (b)(6). (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[108640539]
The customer stated that they received erroneous results for one patient sample tested for etoh2 ethanol gen. 2 (etoh) on an unknown roche analyzer. The sample initially resulted with an etoh value of 5. 06 g/l. The sample was automatically repeated, resulting as 5. 25 g/l. An erroneous result was reported outside of the laboratory to medical personnel. The doctor did not believe the values since they did not meet the clinical picture of the patient. No adverse events were alleged to have occurred with the patient. The model and serial number of the roche analyzer used were asked for, but not provided. The investigation was unable to find a definitive root cause. Product labeling for the etoh reagent instructs the customer to not use the automatic repeat function for repeating samples.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1823260-2018-01543 |
| MDR Report Key | 7525586 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2018-05-18 |
| Date of Report | 2018-05-18 |
| Date of Event | 2018-03-07 |
| Date Mfgr Received | 2018-04-30 |
| Date Added to Maude | 2018-05-18 |
| 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 | ETHANOL GEN.2 |
| Generic Name | ALCOHOL DEHYDROGENASE, SPECIFIC REAGENT FOR ETHANOL ENZYME METHOD |
| Product Code | DML |
| Date Received | 2018-05-18 |
| Model Number | NA |
| Catalog Number | 05967104190 |
| Lot Number | ASKU |
| 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 | 2018-05-18 |