MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01 report with the FDA on 2010-11-16 for PRISM HTLV-I/HTLV-II 6A53-48 manufactured by Abbott Laboratories.
[1677714]
The customer states that one patient sample generated repeat reactive results with the prism htlv-1/htlv-2 assay of s/co 1. 14, 1. 09 and 1. 28. The sample was non-reactive upon confirmatory testing. No suspect results were reported from the lab. No specific information was provided regarding the specimen or patient. There is no impact to patient management reported.
Patient Sequence No: 1, Text Type: D, B5
[8801815]
(b)(4). No returns were made available from the customer site for this evaluation. The evaluation began with a review of the tracking of the 100 member human negative population for reagent lot number 88652hn00 for delta value, mean s/co (sample/cutoff) and maximum s/co. No run rule violations occurred indicating that this lot is not compromised regarding specificity. To evaluate the specificity performance of the reagent lot a total of eight replicates of an htlv specificity panel were analyzed on both sub-channels. All generated s/co results for each individual replicate were within specifications (less than 0. 80 s/co) and no false reactive results were obtained. Testing was performed on a retained kit of prism htlv-i/htlv-ii assay kit, list number 6a53-48, lot number 88652hn00. All generated data demonstrate that the performance of the prism htlv-i/htlv-ii assay kit, list number 6a53-48, lot number 88652hn00 is not compromised. A review of complaint tracking and trending metrics was performed and identified no adverse trends in conjunction with the complaint issue currently under evaluation. The abbott prism htlv-i/htlv-ii reagent, ln 6a53-48 package insert contains information to address the customer's current issue. Based on the current evaluation, it was determined that the prism htlv-i/htlv-ii reagent, list number 6a53-48, lot number 88652hn00, is performing acceptably. A product malfunction was not identified. Evaluation, method: review of complaint tracking and trending.
Patient Sequence No: 1, Text Type: N, H10
[8975058]
(b)(4). This report is being filed on an international product, prism htlv-i/htlv-ii, list number 6a53 that has a similar product distributed in the u. S. , prism htlv-i/htlv-ii, list number 6e50. An investigation is in process. A follow-up report will be submitted when the investigation is complete.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1415939-2010-00534 |
| MDR Report Key | 1900668 |
| Report Source | 01 |
| Date Received | 2010-11-16 |
| Date of Report | 2010-11-03 |
| Date Mfgr Received | 2010-11-22 |
| Device Manufacturer Date | 2010-06-01 |
| Date Added to Maude | 2011-05-26 |
| 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 | 2010-11-16 |
| Catalog Number | 6A53-48 |
| Lot Number | 88652HN00 |
| Device Expiration Date | 2011-08-26 |
| 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 | 2010-11-16 |