MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2009-12-28 for PRISM HTLV-I/HTLV-II 6E50-68 manufactured by Abbott Laboratories.
[1428460]
Reporter alleged the customer obtained the results of 210 mg/dl and 98 mg/dl back to back within 10 minutes on the aviva system. No actions were reported taken or treatment received. No adverse event reported. A request was made for the return of the affected product.
Patient Sequence No: 1, Text Type: D, B5
[1450568]
The customer stated that increased initial and repeat reactive prism htlv i/ii have been observed on a prism analyzer for the months of (b)(6) and (b)(6) of 2009. Patient specific data was not provided. There was no adverse impact to patient management reported.
Patient Sequence No: 1, Text Type: D, B5
[8300490]
(b)(4) 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
[8788789]
(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 | 1415939-2009-01207 |
| MDR Report Key | 1565233 |
| Report Source | 05 |
| Date Received | 2009-12-28 |
| Date of Report | 2009-12-17 |
| Date of Event | 2009-12-17 |
| Date Mfgr Received | 2010-08-17 |
| Device Manufacturer Date | 2009-09-24 |
| 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 | 2009-12-28 |
| Catalog Number | 6E50-68 |
| Lot Number | 77622M100 |
| ID Number | 77620M100, EXP 7/18/10 |
| Device Expiration Date | 2010-07-04 |
| 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 | 2009-12-28 |