MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2008-04-01 for PRISM HTLV-I/HTLV-II 6E50-68 manufactured by Abbott Laboratories.
[19155248]
The customer generated a discrepant pt result between the abbott prism htlv-i/htlv-ii assay and the abbott htlv-l/ii eia. The donor sample tested non-reactive with prism htlv-l/htlv-ii in 2008, with an aliquot from a blood collection bag that was stored frozen. A serum sample from this donor previously tested repeat reactive in 2006 with abbott htlv-i/ii eia. The sample also tested htlv-1 positive by western blot in 2006. The customer was performing validation testing on the prism analyzer. There was no impact to pt management.
Patient Sequence No: 1, Text Type: D, B5
[19326401]
Additional info: device not returned; however, a sample was returned for eval. An aliquot of the discrepant sample has been received and testing of this sample is in process. The prism htlv-i/htlv-ii list 6e50 package insert states in the specimen collection and preparation for analysis section, that some specimens that have undergone multiple freeze thaw cycles or have been store for prolonged periods may give erroneous or inconsistent test results. The sample for which the discrepant test result was observed had been stored frozen since 2006 and the number or freeze/thaw cycles was unknown. Evaluation: 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
| Report Number | 1415939-2008-00042 |
| MDR Report Key | 1023670 |
| Report Source | 05 |
| Date Received | 2008-04-01 |
| Date of Report | 2008-03-04 |
| Date of Event | 2008-02-24 |
| Date Mfgr Received | 2008-03-04 |
| Device Manufacturer Date | 2008-01-01 |
| Date Added to Maude | 2008-08-11 |
| 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 |
| Reporter Occupation | MEDICAL TECHNOLOGIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | SUDARSHAN HEBBAR, MD, D-3MQC, AP6B |
| Manufacturer Street | 100 ABBOTT PARK RD. |
| Manufacturer City | ABBOTT PARK IL 600646112 |
| Manufacturer Country | US |
| Manufacturer Postal | 600646112 |
| Manufacturer Phone | 8479379677 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PRISM HTLV-I/HTLV-II |
| Generic Name | CHLIA FOR THE QUALITATIVE DETECTION OF ANTI-HTLV-I/HTLV-II |
| Product Code | LRM |
| Date Received | 2008-04-01 |
| Model Number | NA |
| Catalog Number | 6E50-68 |
| Lot Number | 54798M101 |
| ID Number | NA |
| Device Expiration Date | 2008-05-04 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 1021231 |
| Manufacturer | ABBOTT LABORATORIES |
| Manufacturer Address | 100 ABBOTT PARK RD. ABBOTT PARK IL 600643500 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2008-04-01 |