MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,06 report with the FDA on 2011-06-17 for ETHYL ALCOHOL 11868152190 manufactured by Roche Diagnostics.
[2014792]
The user received questionable ethanol results for one patient sample from the analytical p module serial number (b)(4). The results were -10 mg/l, -6 mg/l and 148 mg/l. The result of 148 mg/l was reported outside the laboratory. On (b)(6) 2011, the customer retested the sample with manual dilutions. The results with a 1:10 dilution were -1. 6 mg/l and -1. 7 mg/l. The result with a 1:50 dilution was 0. 6 mg/l. The patient claimed to have not drunk any alcohol and was removed from a liver transplant list. The user believed the result of 148 mg/l was generated when the sample was inadvertently tested with a 1:50 dilution that had been programmed for a previous sample.
Patient Sequence No: 1, Text Type: D, B5
[9013897]
This event occurred in (b)(6).
Patient Sequence No: 1, Text Type: N, H10
[9197233]
Additional information was received stating the sample in question was tested by gc-ms (gas chromatography-mass spectroscopy) and the result was negative for ethanol.
Patient Sequence No: 1, Text Type: N, H10
[9216471]
Additional information was received providing updated information for the following medwatch fields: date of birth was (b)(6) and age at time of event was (b)(6). Sex was male. Relevant tests/laboratory data, including dates: the ethanol result from (b)(6) 2011 was <50 and the ethanol result from (b)(6) 2011 was <50. Other relevant history, including preexisting medical conditions- cirrhosis. Concomitant medical products and therapy dates- vitamin k, spironolactone, calcichew d3 forte and codeine phosphate. Date received by manufacturer was (b)(6) 2011. The patient has now been accepted onto the liver transplant list.
Patient Sequence No: 1, Text Type: N, H10
[9565989]
After further investigation, the specific root cause could not be determined. Further investigation was not possible due to missing information. It was suspected a dilution factor for a previous sample could have could have been applied to this sample if the user did not confirm the removal of the dilution in the test selection screen. The patient did not receive any treatment and did not lose any treatment due to the event. The taking of blood samples and the testing to prove abstinence of alcohol should be done only by well trained personnel and in case of positive testing the sample should be immediately retested, all conditions - as in this case, a dilution factor for a previous (other) sample could have taken over by not verifying the "sample volume/dilution" in test selection screen - are to be controlled before the positive testing is reported out of laboratory.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1823260-2011-03319 |
| MDR Report Key | 2132642 |
| Report Source | 01,05,06 |
| Date Received | 2011-06-17 |
| Date of Report | 2011-11-30 |
| Date of Event | 2011-05-13 |
| Date Mfgr Received | 2011-05-24 |
| Date Added to Maude | 2011-06-17 |
| 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 JENNIFER WOLFGRAM |
| Manufacturer Street | 9115 HAGUE ROAD NA |
| Manufacturer City | INDIANAPOLIS IN 46250 |
| Manufacturer Country | US |
| Manufacturer Postal | 46250 |
| Manufacturer Phone | 3175217008 |
| Manufacturer G1 | ROCHE DIAGNOSTICS GMBH |
| Manufacturer Street | SANDHOFERSTRASSE 116 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 | ETHYL ALCOHOL |
| Generic Name | NAD-NADH, SPECIFIC REAGENT FOR ALCOHOL ENZYME METHOD |
| Product Code | DML |
| Date Received | 2011-06-17 |
| Model Number | NA |
| Catalog Number | 11868152190 |
| Lot Number | ASKU |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| 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 | 2011-06-17 |