MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2009-12-22 for PRISM HTLV-I/HTLV-II 6E50-68 manufactured by Abbott Laboratories.
[1254896]
The customer stated they have observed higher initial reactive rates and repeat reactive rates for prism htlv than those in the package insert. The package insert lists the initial reactive htlv rate to be 0. 01 to 0. 11% and the repeat reactive htlv rate to be 0. 00 to 0. 09%. The customer observed an initial reactive htlv rate of 0. 20% and a repeat reactive htlv rate of 0. 16%. The customer sends all htlv repeat reactive samples out for confirmation testing. There was no adverse impact to patient management reported.
Patient Sequence No: 1, Text Type: D, B5
[8349503]
(b)(4) - investigation in process, no method, results or conclusion code can be chosen at this time. This is an initial report. An investigation is in process. A final report will be submitted when the investigation is complete.
Patient Sequence No: 1, Text Type: N, H10
[8520719]
(b)(4), evaluation, method: field data related to the quality issue within the complaint (elevated reactive rates) from multiple customers and reagent kits from lot 74612m100 were reviewed in this investigation. A review of field data was performed. Initial and repeat reactive rates of lot 74612m100 were compared to the upper 95% confidence limits in the prism htlv-i/htlv-ii package insert (commodity 34-4547/r2) for the combined serum/plasma population, as well as for the serum population. No statistical difference was found. A product deficiency has been identified in that prism htlv-i/htlv-ii reagent kit list 06e50-68 lots 74612m100 is exhibiting initial and/or repeat reactive rates greater than the package insert upper 95% confidence limits. An investigation has been initiated to determine cause and improve reactive rates.
Patient Sequence No: 1, Text Type: N, H10
[18113698]
Patient Sequence No: 1, Text Type: D, B5
[18285469]
(b)(4) - evaluation: 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. 30 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 7/30/08. 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 | 1415939-2009-01204 |
| MDR Report Key | 1563157 |
| Report Source | 05 |
| Date Received | 2009-12-22 |
| Date of Report | 2009-12-17 |
| Date of Event | 2009-12-17 |
| Date Mfgr Received | 2010-08-17 |
| Device Manufacturer Date | 2009-06-24 |
| 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 | 2009-12-22 |
| Catalog Number | 6E50-68 |
| Lot Number | 74612M100 |
| Device Expiration Date | 2010-07-18 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| 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 | 2009-12-22 |