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 2018-06-06 for ALBT2 TINA-QUANT ALBUMIN GEN.2 04469658190 manufactured by Roche Diagnostics.
[110594985]
Unique identifier (udi)#: (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[110594986]
During instrument comparison testing, the customer identified an incorrect result for 1 patient urine sample tested for albt2 tina-quant albumin gen. 2 (albt2) on a cobas 6000 c (501) module that had been reported outside of the laboratory. The initial albt2 result from an aliquot tube was 255 mg/l on the c501 module in question. This result was reported outside of the laboratory. The customer performed numerous comparisons and precision studies to troubleshoot the issue. On (b)(6) 2108 the patient sample was repeated twice on a different c501 module with results of 146. 3 mg/l with a data flag and 3793. 3 mg/l. On (b)(6) 218 the result was corrected to 3793. 3 mg/l. No adverse event occurred. The c501 module serial number was (b)(4). The field service engineer (fse) visited the customer site and found that the reagent was faulty. The reagent was replaced and the customer ran multiple samples and received expected results. The customer has not had any further issues since the reagent was replaced.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1823260-2018-01763 |
| MDR Report Key | 7574374 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2018-06-06 |
| Date of Report | 2018-06-06 |
| Date of Event | 2018-05-18 |
| Date Mfgr Received | 2018-05-19 |
| Date Added to Maude | 2018-06-06 |
| 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 | ALBT2 TINA-QUANT ALBUMIN GEN.2 |
| Generic Name | ALBUMIN, ANTIGEN |
| Product Code | DCF |
| Date Received | 2018-06-06 |
| Model Number | NA |
| Catalog Number | 04469658190 |
| Lot Number | 30049101 |
| ID Number | NA |
| Device Expiration Date | 2019-08-31 |
| 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 | 2018-06-06 |