MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 08 report with the FDA on 2010-01-15 for WAMPOLE LABORATORIES STAPH LATEX KIT 56D6 manufactured by Nerl Diagnostics, Llc.
[15625510]
On (b)(6) 2009, it was confirmed that the staph latex reagent was not sufficiently reactive with the recommended positive control. The staph latex kit is a latex agglutination kit in which the reagent should agglutinate when tested with a known positive control organism (b)(6). When the kits in question were tested with the positive control, as recommended in the package insert, weakened agglutination was observed.
Patient Sequence No: 1, Text Type: D, B5
[15988311]
Add'l lot # 1110049. In response to the receipt of these complaints, we conducted an investigation. Both of these lots were manufactured from the same bulk lot of staph latex reagent. We repeated quality control release testing on retention kits as well as returned kits. Our testing indicated reduced reactivity (out of specification) of the latex reagent in the presence of the recommended positive control. Based on these results, we conducted a risk assessment. A decision was made to recall both lots of product which were shipped to one distributor. We are working with that distributor to ensure that all end users are notified of the recall. A sample letter to the distributor is attached. In addition, to ensure that this product malfunction does not recur, the following measures were taken. The sop for stock culture maintenance (b)(4) has been updated to include the organisms utilized for the qc bulk and release testing for the staph latex kit. Appropriate qc personnel have been trained to the new revision (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1215667-2010-00001 |
| MDR Report Key | 1588030 |
| Report Source | 08 |
| Date Received | 2010-01-15 |
| Date of Report | 2010-01-15 |
| Date of Event | 2009-12-15 |
| Date Mfgr Received | 2009-12-15 |
| Device Manufacturer Date | 2009-09-01 |
| Date Added to Maude | 2010-09-20 |
| 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 | TINA LOMBARI |
| Manufacturer Street | 14 ALMEIDA AVE |
| Manufacturer City | EAST PROVIDENCE RI 02914 |
| Manufacturer Country | US |
| Manufacturer Postal | 02914 |
| Manufacturer Phone | 4018242046 |
| Single Use | 3 |
| Remedial Action | RL |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | WAMPOLE LABORATORIES STAPH LATEX KIT |
| Product Code | JWX |
| Date Received | 2010-01-15 |
| Returned To Mfg | 2009-12-15 |
| Catalog Number | 56D6 |
| Lot Number | 0919119 |
| Device Expiration Date | 2012-06-03 |
| Operator | OTHER |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | NERL DIAGNOSTICS, LLC |
| Manufacturer Address | 14 ALMEIDA AVE. EAST PROVIDENCE RI 02914 US 02914 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2010-01-15 |