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 2017-03-02 for DIG DIGOXIN 20737836322 manufactured by Roche Diagnostics.
[68979502]
This event occurred in (b)(6). (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[68979503]
The customer stated that they received erroneous results for one patient sample tested for dig digoxin on a cobas 6000 c (501) module - c501. No erroneous results were reported outside of the laboratory. The sample initially resulted as 0. 70 ng/ml. Since the result was low, the customer repeated the sample and it resulted as 0. 44 ng/ml. The customer repeated the sample a second time and it resulted as 0. 52 ng/ml. The customer did not know which result was correct. The customer ran precision studies and the results were ok. The customer changed the reagent pack and repeated the patient sample. The repeat results from the new pack were reproducible, with results of 0. 65 ng/ml and 0. 67 ng/ml. The patient was not adversely affected. The c501 analyzer serial number was asked for, but not provided. The issue was likely related to the reagent pack. Most likely, an aging effect of the reagent due to shipping or storage conditions affected the precision of the assay at the low end of the measuring range.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1823260-2017-00446 |
| MDR Report Key | 6372502 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2017-03-02 |
| Date of Report | 2017-03-02 |
| Date of Event | 2017-02-10 |
| Date Mfgr Received | 2017-02-10 |
| Date Added to Maude | 2017-03-02 |
| 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 | DIG DIGOXIN |
| Generic Name | ENZYME IMMUNOASSAY, DIGOXIN |
| Product Code | KXT |
| Date Received | 2017-03-02 |
| 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 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 | 2017-03-02 |