MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2011-08-30 for ANTI-HUMAN GLOBULIN ANTI-IGG SOLIDSCREEN II 806516100 manufactured by Bio-rad Medical Diagnostics Gmbh.
[2161171]
The customer reported discrepant reactions of a known antibody positive sample on solidscreen on tango. In the first run the sample reacted negatively. Next day during a second run the sample reacted positively. Customer has sent us two samples of the affected patient but not the allegedly defective product. Therefore both patient's samples were tested with our retention sample of anti-human globulin, anti-igg solidscreen ii. Both reacted positively with biotestcell laboratory confirmed the correct function of the allegedly defective anti-human globulin, anti-igg solidscreen ii lot. A review of the batch record documentation showed no irregularities which might have affected negatively the complained lot's quality.
Patient Sequence No: 1, Text Type: D, B5
[9331680]
A tango service intervention was performed and the left pipettor needle showed a large amount of crystals and deposit. The needle was replaced and some tubing lines corresponding to the pipettor. No other errors were detected. The inconsistency in the results ((b)(6) 2011 vs. (b)(6) 2011) together with the findings of the service engineer make us believe that the residues present at the left pipettor probe adversely influenced the instrument performance and occasionally resulted in insufficient/inaccurate uptake or dispensing of plasma. Since the cleaning of the pipettor probes is part of the daily maintenance conducted by the user, the reported issue could probably have been prevented by following the guidelines and working in accordance to the user manual.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9610824-2011-00119 |
| MDR Report Key | 2261764 |
| Report Source | 05 |
| Date Received | 2011-08-30 |
| Date of Report | 2011-08-30 |
| Date of Event | 2011-08-04 |
| Date Mfgr Received | 2011-08-05 |
| Date Added to Maude | 2012-05-21 |
| 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 | 0 |
| Manufacturer Contact | DR MARC GORZELLIK |
| Manufacturer Street | INDUSTRIESTRASSE 1 |
| Manufacturer City | DREIEICH 63303 |
| Manufacturer Country | GM |
| Manufacturer Postal | 63303 |
| Manufacturer Phone | 103801528 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ANTI-HUMAN GLOBULIN ANTI-IGG SOLIDSCREEN II |
| Generic Name | AHG ANTI-IGG SOLIDSCREEN |
| Product Code | DEW |
| Date Received | 2011-08-30 |
| Catalog Number | 806516100 |
| Lot Number | 8102140-04 |
| Device Expiration Date | 2012-07-26 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BIO-RAD MEDICAL DIAGNOSTICS GMBH |
| Manufacturer Address | INDUSTRIESTRASSE 1 DREIEICH D-63303 GM D-63303 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-08-30 |