MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05 report with the FDA on 2013-02-15 for PRISM HTLV-I/HTLV-II 06A53-48 manufactured by Abbott Laboratories.
[10575875]
A retained kit of prism htlv-1 / htlv-2 reagent, list number 06a53-48 lot number 21105li00 was calibrated on one prism analyzer. To evaluate the performance with regard to specificity, replicates of an htlv-1 / htlv-2 specificity panel were tested. Results were within typical ranges and no false reactive results were obtained. A review of the human negative population, routinely evaluated during release testing, revealed no indications that the specificity of the reagent lot might be adversely affected. The mean value across all panel members for this lot number corresponds to the mean observed for all lot numbers. A review of complaint tracking and trending metrics was performed and identified no adverse trends in conjunction with the complaint issue currently under evaluation. Additionally, the performance was investigated by completing a review of manufacturing and testing records for the affected reagent lot. This review did not reveal any events or issues that may have impacted reagent performance in relation to the current complaint issue. The prism htlv-1/htlv-2 assay package insert contains information to address the current customer issue. Based on the results of the current evaluation, it has been determined that the prism htlv-1 / htlv-2 reagent, list number 06a53-48, lot number 21105li00, is performing acceptably.
Patient Sequence No: 1, Text Type: N, H10
[21261312]
The customer reports an increase in repeat (b)(6) rates for the prism htlv-i/htlv-ii assay when they switched to reagent lot 21105li00. This occurred during the timeframe of (b)(6) 2013. This has resulted in donors who previously tested (b)(6) to now test (b)(6). The customer provided the following example: donor 2: initial (b)(6) result of (b)(6); repeat (b)(6) results of (b)(6). Previous (b)(6) result of (b)(6) on (b)(6) 2009 with reagent lot 71331hn00. To date, the customer has seen their repeat (b)(6) rate rise to 0. 05%. There is no further impact to donor management reported.
Patient Sequence No: 1, Text Type: D, B5
[21501331]
An evaluation is in process. A follow-up report will be submitted when the evaluation is complete. This report is being filed on an international product, list number 06a53 that has a similar product distributed in the us, list number 06e50. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1415939-2013-00056 |
| MDR Report Key | 2963314 |
| Report Source | 01,05 |
| Date Received | 2013-02-15 |
| Date of Report | 2013-02-05 |
| Date Mfgr Received | 2013-02-22 |
| Device Manufacturer Date | 2012-11-01 |
| Date Added to Maude | 2013-02-21 |
| 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 | NOEMI ROMERO-KONDOS, RN BSN |
| Manufacturer Street | 100 ABBOTT PARK ROAD DEPT. 09B9, LCCP1-3 |
| Manufacturer City | ABBOTT PARK IL 600643537 |
| Manufacturer Country | US |
| Manufacturer Postal | 600643537 |
| Manufacturer Phone | 847937-512 |
| Manufacturer G1 | ABBOTT LABORATORIES |
| Manufacturer Street | 100 ABBOTT PARK ROAD |
| Manufacturer City | ABBOTT PARK IL 60064350 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 60064 3500 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PRISM HTLV-I/HTLV-II |
| Product Code | MTP |
| Date Received | 2013-02-15 |
| Catalog Number | 06A53-48 |
| Lot Number | 21105LI00 |
| Device Expiration Date | 2013-12-14 |
| Operator | OTHER |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ABBOTT LABORATORIES |
| Manufacturer Address | 100 ABBOTT PARK ROAD ABBOTT PARK IL 60064350 US 60064 3500 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-02-15 |