MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06,07 report with the FDA on 2012-03-15 for ALBUMIN 11970909216 manufactured by Roche Diagnostics.
[2406961]
The customer representative received an email stating the customer received questionable albumin (alb) results on their modular analytics p-module, serial number (b)(4). The customer noticed the erroneous alb results due to the total protein comparison they use on all samples. The customer believed they might have had a defective reagent cartridge. The customer stated there was almost a plastic divider in the bottle, formed where the bottle seams were, which may have caused or exacerbated foaming. The customer stated there appeared to be a lot of bubbles on the top that resulted in incorrect results being reported. The customer replaced the reagent cartridge, recalibrated, and ran controls. The customer felt everything should be back to normal at this time. Eighteen patients were found to have been incorrectly reported and were corrected. Repeat testing was performed on another p-module, serial number (b)(4). Patient 1 had an initial alb result of 6. 6 g/dl. The repeat result was 3. 9 g/dl. Patient 2 had an initial alb result of 6. 6 g/dl. The repeat result was 3. 3 g/dl. Patient 3 had an initial alb result of 6. 6 g/dl. The repeat result was 3. 9 g/dl. Patient 4 had an initial alb result of 7. 0 g/dl. The repeat result was 3. 9 g/dl. Patient 5 had an initial alb result of 6. 6 g/dl. The repeat result was 3. 9 g/dl. Patient 6 had an initial alb result of 6. 4 g/dl. The repeat result was 3. 1 g/dl. Patient 7 had an initial alb result of 6. 6 g/dl. The repeat result was 3. 5 g/dl. Patient 8 had an initial alb result of 6. 6 g/dl. The repeat result was 3. 2 g/dl. Patient 9 had an initial alb result of 6. 6 g/dl. The repeat result was 3. 9 g/dl. Patient 10 had an initial alb result of 6. 7 g/dl. The repeat result was 3. 9 g/dl. Patient 11 had an initial alb result of 6. 6 g/dl. The repeat result was 3. 4 g/dl. Patient 12 had an initial alb result of 6. 6 g/dl. The repeat result was 3. 7 g/dl. Patient 13 had an initial alb result of 6. 5 g/dl. The repeat result was 2. 5 g/dl. Patient 14 had an initial alb result of 4. 1 g/dl. The repeat result was 2. 0 g/dl. Patient 15 had an initial alb result of 6. 4 g/dl. The repeat result was 2. 9 g/dl. Patient 16 had an initial alb result of 6. 6 g/dl. The repeat result was 3. 5 g/dl. Patient 17 had an initial alb result of 6. 6 g/dl. The repeat result was 2. 9 g/dl. Patient 18 had an initial alb result of 6. 6 g/dl. The repeat result was 4. 2 g/dl. There were no adverse events. The customer declined a service visit believing the reagent bottle was the issue.
Patient Sequence No: 1, Text Type: D, B5
[9691057]
It was unknown if the initial reporter sent report to the fda.
Patient Sequence No: 1, Text Type: N, H10
[21149711]
The customer returned reagent for investigation. An increase in bubbles due to the plastic divider was not observed. Quality control recovery was within specification. A specific root cause for this event could not be identified. No adverse event was reported.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1823260-2012-01444 |
| MDR Report Key | 2492934 |
| Report Source | 05,06,07 |
| Date Received | 2012-03-15 |
| Date of Report | 2012-05-29 |
| 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 | N |
| 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 |