MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2010-06-30 for PRISM HTLV-I/HTLV-II 6E50-68 manufactured by Abbott Laboratories.
[1341003]
The account generated false reactive prism htlv-i/htlv-ii results (reagent lots 81856m100 and 81858m100) on 12 plasmapheresis donors who tested western blot negative. The account stated the donors were repeat, long time donors who previously tested htlv-i/htlv-ii negative. No specific testing or patient data was provided for the donors. No impact to patient management was reported.
Patient Sequence No: 1, Text Type: D, B5
[8581230]
(b)(4). Complaint tracking and trending data reviewed. Results of this investigation indicated that prism htlv-i/htlv-ii lots 81856m100 and 81858m100 are performing according to product label claims. The investigation for prism htlv-i/htlv-ii reagent lots 81856m100 and 81858m100 included a review of field data reported to our prism metrics database. For lot 81856m100, a total of (b)(4) samples had been tested across multiple customer sites at the time of the review. The overall initial and repeat reactive rates were calculated to be (b)(4), respectively. The calculated values were compared to the upper 95% confidence limits for initial and repeat reactive rates within the prism htlv-i/htlv-ii package insert (commodity 34-4547/r2). Both the initial and repeat reactive rates observed for lot 81856m100 were less than the upper 95% confidence limits ((b)(4)) for a combined plasma and serum population. For lot 81858m100, a total of (b)(4) samples had been tested with initial and repeat reactive rates of (b)(4), respectively, which are also less than the package insert upper 95% confidence limits. As plasma is the sample type primarily used at the customer facility for testing with prism htlv-i/htlv-ii, a review of field data from customer sites known to be using primarily plasma samples was performed. For lot 81856m100, a total of (b)(4) plasma samples had been tested across multiple customer sites. The initial and repeat reactive rates for the plasma population were calculated to be (b)(4), respectively. These reactive rates are less than the package insert upper 95% confidence limits for a plasma population ((b)(4)). For lot 81858m100, the number of samples tested at customer sites using primarily plasma was not sufficient to evaluate reactive rate performance for the plasma population. From this investigation, it is concluded that prism htlv-i/htlv-ii reagent lots 81856m100 and 81858m100 are meeting product label claims.
Patient Sequence No: 1, Text Type: N, H10
[8635912]
(b)(4). An investigation is in process. A follow-up report will be submitted when the investigation is complete. H3 other text : an investigation is in process.
Patient Sequence No: 1, Text Type: N, H10
[8762771]
(b)(4): reactivity originating from the htlv-i viral lysate. An investigation was initiated to determine if there were actions that could be taken to improve reactive rates with the prism htlv-i/htlv-ii assay. The results of the additional investigation is below. Thirty of 79 prism htlv-i / htlv-ii reagent lots, list number 06e50-68, have exhibited initial reactive rates (irr) and/or repeat reactive rates (rrr) that exceed the package insert 95% confidence interval upper limit. Multiple customer complaints related to reactive rates from several sites representing various geographic areas for these lots have been received since (b)(6) 2008. There was no impact to product functionality or product performance. The probable cause of some reagent lots exhibiting irr and/or rrr that exceed the package insert 95% confidence interval upper limit is that these clinical results were obtained from the 3 clinical lots combined and does not accurately represent the individual clinical lot irr and rrr performance. A contributing factor for the higher than expected repeat reactive rates observed at multiple customer sites for the prism htlv-i/htlv-ii assay is a sample-specific antibody interaction with the microparticle and probe components of the assay reagents. The target of this reactivity originates from the htlv-i viral lysate.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1415939-2010-00374 |
| MDR Report Key | 1741973 |
| Report Source | 05 |
| Date Received | 2010-06-30 |
| Date of Report | 2010-06-04 |
| Date Mfgr Received | 2010-08-17 |
| Device Manufacturer Date | 2010-02-08 |
| Date Added to Maude | 2010-09-15 |
| 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 | 0 |
| Manufacturer Contact | NOEMI KONDOS RN, BSN |
| Manufacturer Street | 200 ABBOTT PARK ROAD DEPT. 09B9, AP50 |
| Manufacturer City | ABBOTT PARK IL 600643537 |
| Manufacturer Country | US |
| Manufacturer Postal | 600643537 |
| Manufacturer Phone | 8479375120 |
| 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 |
| Generic Name | FOR DETECTION OF HTLV-I/ HTLV-II ANTIBODIES IN HUMAN SERUM OR PLASMA |
| Product Code | MTP |
| Date Received | 2010-06-30 |
| Catalog Number | 6E50-68 |
| Lot Number | 81856M100 |
| Device Expiration Date | 2010-07-25 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| 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 | 2010-06-30 |