MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2012-03-15 for ALBUMIN 11970909216 manufactured by Roche Diagnostics.
[2406954]
The customer reported that they had questionable results for twenty five patient samples tested for albumin bcg method (albumin). Of the twenty five patient samples, the customer provided results for ten patient samples. All ten patient samples were found to have erroneous results. All initial results were reported outside of the laboratory. A floor nurse questioned the high initial albumin results which caused the customer to pull and repeat the albumins. All repeat results were considered to be correct and corrected reports were issued for the repeats of all 25 patient samples. Sample one initially resulted as 6. 47 g/dl and repeated as 3. 63 g/dl. Sample two initially resulted as 6. 69 g/dl and repeated as 4. 49 g/dl. Sample three initially resulted as 6. 40 g/dl and repeated as 3. 93 g/dl. Sample four initially resulted as 6. 59 g/dl and repeated as 2. 99 g/dl. Sample five initially resulted as 6. 66 g/dl and repeated as 3. 69 g/dl. Sample six initially resulted as 6. 54 g/dl and repeated as 3. 66 g/dl. Sample seven initially resulted as 6. 52 g/dl and repeated as 3. 78 g/dl. Sample eight initially resulted as 6. 52 g/dl and repeated as 3. 18 g/dl. Sample nine initially resulted as 6. 38 g/dl and repeated as 3. 97 g/dl. Sample ten initially resulted as 6. 67 g/dl and repeated as 3. 82 g/dl. The patients were not adversely affected by the event. The analyzer was an analytical p module with serial number (b)(4). The customer declined a service visit and stated that the reagent bottle had what appeared to be plastic pieces throughout the entire bottle.
Patient Sequence No: 1, Text Type: D, B5
[9785432]
It was unknown if the initial reporter sent report to the fda.
Patient Sequence No: 1, Text Type: N, H10
[9887946]
A specific root cause could not be determined. Investigations conclude that there is no evidence connecting the plastic particles in the bottle and the observed discrepant results. No reagent nor packaging abnormality is responsible for the observed outliers. The issue could not be reproduced. There is no general issue at the customer site and the problem did not recur after reagent bottle change.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1823260-2012-01441 |
| MDR Report Key | 2492616 |
| Report Source | 05,06 |
| Date Received | 2012-03-15 |
| Date of Report | 2012-05-22 |
| Date of Event | 2012-03-01 |
| Date Mfgr Received | 2012-03-02 |
| Date Added to Maude | 2012-03-15 |
| 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 JENNIFER WOLFGRAM |
| Manufacturer Street | 9115 HAGUE ROAD NA |
| Manufacturer City | INDIANAPOLIS IN 46250 |
| Manufacturer Country | US |
| Manufacturer Postal | 46250 |
| Manufacturer Phone | 3175217008 |
| Manufacturer G1 | ROCHE DIAGNOSTICS GMBH |
| Manufacturer Street | SANDHOFERSTRASSE 116 NA |
| Manufacturer City | MANNHEIM (BADEN-WURTTEMBERG) 68305 |
| 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 |
| Generic Name | BROMCRESOL GREEN DYE-BINDING, ALBUMIN |
| Product Code | CIX |
| Date Received | 2012-03-15 |
| Model Number | NA |
| Catalog Number | 11970909216 |
| Lot Number | 64741801 |
| ID Number | NA |
| Device Expiration Date | 2012-11-30 |
| 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 | 2012-03-15 |