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 2017-02-19 for ALBUMIN TINA-QUANT ALBUMIN 03576108190 manufactured by Roche Diagnostics.
[67930132]
Unique identifier (udi)#: (b)(4). This event occurred in (b)(6).
Patient Sequence No: 1, Text Type: N, H10
[67930133]
The customer received a questionable albumin tina-quant result for one patient sample from an unknown roche analyzer. The initial result was 415. 48 mg/l with a data flag. The repeat result was 339. 55 mg/l. The repeat result with a 1:10 dilution was 237. 28 mg/l. Information concerning if any erroneous result was reported outside the laboratory was requested, but it was unknown. The patient was not adversely affected.
Patient Sequence No: 1, Text Type: D, B5
[71366958]
Based on the provided data, the root cause seemed to be sample specific and caused by an unknown interference possibly from a medication and /or a gammopathy. An analyzer issue was excluded as the interference could be diluted out and the qc data was reported to be acceptable.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1823260-2017-00371 |
| MDR Report Key | 6342578 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2017-02-19 |
| Date of Report | 2017-03-21 |
| Date of Event | 2017-01-24 |
| Date Mfgr Received | 2017-02-02 |
| Date Added to Maude | 2017-02-19 |
| 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 | ALBUMIN TINA-QUANT ALBUMIN |
| Generic Name | INDICATOR METHOD, PROTEIN OR ALBUMIN (URINARY, NON-QUANT.) |
| Product Code | JIR |
| Date Received | 2017-02-19 |
| Model Number | NA |
| Catalog Number | 03576108190 |
| 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 | 2017-02-19 |