MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2017-10-16 for DIG DIGOXIN 20737836322 manufactured by Roche Diagnostics.
[90539381]
(b)(4).
Patient Sequence No: 1, Text Type: N, H10
[90539382]
The customer complained that after installing a new standby reagent pack of a new lot of dig digoxin, one of their quality controls was within specification but a patient sample quality control was not within specification. The customer installed another dig reagent cassette of the same lot with multiple calibrations but the issue continued. The issue occurred on the cobas 6000 c (501) module serial number (b)(4). The customer was not using the new standby dig reagent lot for diagnostic testing. The current dig reagent lot cassette being used for diagnostic testing was operating on a calibration from (b)(6) 2017. The customer was using patient samples for the other quality control. The customer provided example of an erroneous dig result for two patient samples. Of the data, only the results for one patient sample were a reportable malfunction. The initial dig result was 0. 88 ng/ml and was reported outside of the laboratory. The same sample was tested as a quality control and the dig result was 0. 89 ng/ml with the current dig reagent lot. The same patient sample result was 0. 58 ng/ml with the standby dig reagent lot. After a new calibration of the current dig reagent lot, the result was 0. 61ng/ml and was deemed to be correct. The reported result was corrected. There was no adverse event. The standby dig reagent lot was 22798401 with an expiration date of 30-apr-2018. The current dig reagent lot was 19193501 with an expiration date of 30-sep-2017.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1823260-2017-02318 |
| MDR Report Key | 6951107 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2017-10-16 |
| Date of Report | 2017-10-25 |
| Date of Event | 2017-09-29 |
| Date Mfgr Received | 2017-09-29 |
| Date Added to Maude | 2017-10-16 |
| 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 | 2017-10-16 |
| Model Number | NA |
| Catalog Number | 20737836322 |
| Lot Number | 19193501 |
| ID Number | NA |
| Device Expiration Date | 2017-09-30 |
| 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 | 2017-10-16 |