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 2014-12-22 for DIGOXIN 11820796322 manufactured by Roche Diagnostics.
[13061165]
The investigation identified an interfering factor to streptavidin. The possibility of this interference is covered in product labeling.
Patient Sequence No: 1, Text Type: N, H10
[18728113]
The customer complained of possible interference and questionable results for 3 samples from one patient tested for digoxin. The customer stated the samples were high when tested on a cobas 8000 e 602 module, serial number (b)(4), but were normal when tested with siemens technology. The samples were retested at the request of the doctor because the results did not fit the clinical picture. A sample from (b)(6) 2014 yielded an initial result of 2. 56 ug/l. The repeat result, tested on (b)(6) 2014, was 1. 6 ug/l. A sample from (b)(6) 2014 yielded an initial result of 2. 06 ug/l. The repeat result, tested on (b)(6) 2014, was 1. 0 ug/l. A sample from (b)(6) 2014 yielded an initial result of 1. 19 ug/l. The repeat result, tested on (b)(6) 2014, was 0. 5 ug/l. Initial results for the first two samples were reported outside the laboratory; it is unclear if the initial result for the third sample was reported. The patient's treatment was altered due to the results, but the customer did not provide details. The patient was not harmed by any action taken.
Patient Sequence No: 1, Text Type: D, B5
[18862551]
The event took place in (b)(6).
Patient Sequence No: 1, Text Type: N, H10
[21376098]
Interference testing with the drug, previscan, showed no influence on test results.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1823260-2014-10271 |
| MDR Report Key | 4350752 |
| Report Source | 01,05,06 |
| Date Received | 2014-12-22 |
| Date of Report | 2015-03-25 |
| Date of Event | 2014-11-25 |
| Date Mfgr Received | 2014-12-02 |
| Date Added to Maude | 2014-12-22 |
| 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 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 | DIGOXIN |
| Generic Name | ENZYME IMMUNOASSAY, DIGOXIN |
| Product Code | KXT |
| Date Received | 2014-12-22 |
| Model Number | NA |
| Catalog Number | 11820796322 |
| Lot Number | 179005 |
| ID Number | NA |
| Device Expiration Date | 2015-11-30 |
| 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 46250 US 46250 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-12-22 |