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 LIFESIGN STAPH LATEX 50051 manufactured by Nerl Diagnostics Llc..
[20996448]
On december 15, 2009, it was confirmed that the staph latex reagent was not sufficiently reactive with a known 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 kit in question was tested with the positive control weakened agglutination was observed.
Patient Sequence No: 1, Text Type: D, B5
[21199767]
In response to the receipt of one complaint for this kit lot, and for two other kit lots noted in mrn 1215667-2010-00001, we conducted an investigation. We repeated quality control release testing on retention kits. Our testing indicated reduced reactivity (out of spec) 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 this lot of product which was 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. The bulk lot of staph latex reagent used to manufacture this kit lot was also used for another device. Please refer to mfr report number 1215667-2010-00001. 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). Eval summary: nerl retention sample kit was tested according to qc release testing procedure. During the complaint investigation for lifesign staph latex lot # 1009029, the following results were obtained.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1215667-2010-00002 |
| MDR Report Key | 1588044 |
| 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 | LIFESIGN STAPH LATEX |
| Product Code | JWX |
| Date Received | 2010-01-15 |
| Catalog Number | 50051 |
| Lot Number | 1009029 |
| Device Expiration Date | 2012-06-01 |
| Operator | OTHER |
| Device Availability | N |
| 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 |