MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2008-04-07 for PRISM HTLV-I/HTLV-II 6E50-68 manufactured by Abbott Laboratories.
[811973]
The customer stated a patient sample generated a nonreactive result on the prism htlv-i/htlv-ii assay but was repeat reactive on abbott htlv-i/htlv-ii eia, ortho elisa (biomerieux) and indeterminate on western blot. The customer was performing validation testing on prism, and there was no impact to patient management.
Patient Sequence No: 1, Text Type: D, B5
[8029038]
Device not returned, however, the patient sample was returned for eval. An aliquot of the discrepant sample has been received and testing of the sample is in process. The prism htlv-i/htlv-ii package insert (commodity) states in the specimen collection and preparation for analysis section that some specimens that have undergone multiple freeze/thaw cycles or have been stored frozen 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 of freeze/thaw cycles was unknown. 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 | 1415939-2008-00046 |
| MDR Report Key | 1026170 |
| Report Source | 05 |
| Date Received | 2008-04-07 |
| Date of Report | 2008-03-10 |
| Date of Event | 2008-03-10 |
| Date Mfgr Received | 2008-03-10 |
| Device Manufacturer Date | 2008-01-01 |
| Date Added to Maude | 2008-09-25 |
| 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 | 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 | 2008-04-07 |
| 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 | 1024264 |
| Manufacturer | ABBOTT LABORATORIES |
| Manufacturer Address | 100 ABBOTT PARK RD. ABBOTT PARK IL 600643500 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2008-04-07 |