MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-10-14 for DIG DIGOXIN 20737836322 manufactured by Roche Diagnostics.
[57919214]
(b)(4). This event occurred in (b)(6).
Patient Sequence No: 1, Text Type: N, H10
[57919215]
The customer discovered questionable dig digoxin results from the cobas c501 analyzer when they were compared to the results from the cobas e602 analyzer. The serial numbers of the analyzers involved were requested but were not provided. The customer had been using the assay on the cobas c501 analyzer and the samples were tested between (b)(6) 2016. On (b)(6) 2016, the customer switched to testing the assay on the cobas e602 analyzer. The samples which had been frozen were retested on the cobas e602 for a correlation. Of the data provided for 20 patient samples, only the results for five were discrepant. (b)(6). The results from c501 were released out of laboratory. The patients were not adversely affected. The reagent lot used on the e602 was 184449. The expiration dates were requested but were not provided. The customer had noticed external qc results on the c501 were outside the acceptable range. When the customer started running the assay on the e602 the results of the external qc were within the specifications.
Patient Sequence No: 1, Text Type: D, B5
[59909408]
It was determined the customer had used the non-restandardized version of the digoxin assay for testing on the cobas e602 analyzer and the re-standardized version of the assay on the cobas c501. The difference in the results between the two systems was due to the restandardization of the assay as the prior reference standardization used a non-optimal reference curve. Both versions of the assay performed within their specifications and generated reliable results. There was no device malfunction.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1823260-2016-01571 |
| MDR Report Key | 6030362 |
| Date Received | 2016-10-14 |
| Date of Report | 2016-11-15 |
| Date of Event | 2016-05-03 |
| Date Mfgr Received | 2016-10-03 |
| Date Added to Maude | 2016-10-14 |
| 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 | DIG DIGOXIN |
| Generic Name | ENZYME IMMUNOASSAY, DIGOXIN |
| Product Code | KXT |
| Date Received | 2016-10-14 |
| Model Number | NA |
| Catalog Number | 20737836322 |
| 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 | 2016-10-14 |