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 2017-04-28 for ALBT2 TINA-QUANT ALBUMIN GEN.2 04469658190 manufactured by Roche Diagnostics.
[74055531]
This event occurred in (b)(6). (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[74055533]
The customer received questionable results for two samples from the same patient tested for albt2 tina-quant albumin gen. 2 (alb) on a cobas integra 400 plus (i400+) at the customer laboratory and a cobas 6000 c (501) module - c501 at a second laboratory. The first sample from the patient was tested on the customer's i400+ analyzer and resulted as "between 18 and 20" g/l. The patient went to the hospital where the alb on a siemens instrument was 36 g/l. The doctor believed the 36 g/l result was correct, and stated the result from the i400+ analyzer was too low. The first sample was sent to a second laboratory, and the alb was 18 g/l when measured on a c501 analyzer. The roche alb method is an immunoturbidimetric method, whereas the siemens method is a bromocresol method. The difference in results was believed to be related to the difference in methodology. A reagent cassette of the roche bromocresol alb method was sent to the customer for troubleshooting. A second sample from the patient was then tested on the i400+ using both methods on (b)(6) 2017. The result from the immunoturbidimetric method was 20. 8 g/l and the result from the roche bromocresol alb method was 30. 8 g/l. No adverse events were alleged. The serial numbers of the i400+ and c501 analyzers that were used were requested but not provided.
Patient Sequence No: 1, Text Type: D, B5
[79044485]
Samples from the patient were provided for investigation. The values obtained by the customer were duplicated. Dilution of the samples did not change the results, so it is unlikely that an interferent to the alb assay is present in the samples.
Patient Sequence No: 1, Text Type: N, H10
[132586186]
The bromocresol alb method is less specific than the roche immunoturbidimetric alb method (complained assay), so the bromocresol method can give higher results.
Patient Sequence No: 1, Text Type: N, H10
[132588646]
Quality control recovery was of very high quality, precise, and accurate. Gammopathy interference can not be completely excluded, but based on the dilution experiments, no indication for interference was found. The complained alb reagent is highly specific and can therefore give lower results than other methods.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1823260-2017-00913 |
| MDR Report Key | 6529171 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2017-04-28 |
| Date of Report | 2017-09-19 |
| Date of Event | 2017-04-07 |
| Date Mfgr Received | 2017-04-07 |
| Date Added to Maude | 2017-04-28 |
| 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 | ALBT2 TINA-QUANT ALBUMIN GEN.2 |
| Generic Name | ALBUMIN, ANTIGEN, ANTISERUM, CONTROL |
| Product Code | DCF |
| Date Received | 2017-04-28 |
| Model Number | NA |
| Catalog Number | 04469658190 |
| Lot Number | 21974301 |
| 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 | 2017-04-28 |