MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2009-09-16 for PRISM HTLV-I/HTLV-II 6E50-68 manufactured by Abbott Laboratories.
[1147732]
The customer stated they have observed an increase in repeat reactive rates on the prism htlv i/ii assay since 2009. There were ten repeat reactive samples in two months, all which have not confirmed by supplemental testing at a reference laboratory. The customer stated the majority of these sample were from repeat donors who had never tested reactive previously. No impact to patient management was reported.
Patient Sequence No: 1, Text Type: D, B5
[1708172]
It was reported that during a laparoscopic gastric bypass procedure, all seven trocars had excessive leakage throughout the procedure. A second insufflation machine had to be brought into the room and the pressure level was sent higher than normal. The procedure was prolonged for fifteen minutes. The same trocars were used to complete the procedure. No adverse consequences reported.
Patient Sequence No: 1, Text Type: D, B5
[8381965]
This is an initial report. An investigation is in process. A final report will be submitted when the investigation is complete. An investigation is in process
Patient Sequence No: 1, Text Type: N, H10
[8785299]
(b)(4) - reactivity originating from htlv-i viral lysate. 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 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 | 1415939-2009-01110 |
| MDR Report Key | 1473835 |
| Report Source | 07 |
| Date Received | 2009-09-16 |
| Date of Report | 2009-08-21 |
| Date of Event | 2009-07-01 |
| Date Mfgr Received | 2010-08-17 |
| Device Manufacturer Date | 2009-03-30 |
| Date Added to Maude | 2010-09-13 |
| 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 | 2009-09-16 |
| Catalog Number | 6E50-68 |
| Lot Number | 74604M100 |
| Device Expiration Date | 2010-03-11 |
| 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 | 2009-09-16 |