MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2018-10-09 for PRISM HTLV-I/HTLV-II 06E50-68 manufactured by Abbott Laboratories.
[125326041]
All available patient information was included. Additional patient details are not available. An evaluation is in process. A final report will be submitted when the evaluation is complete. See also manufacturer report number 1415939-2018-00149 for this same event reported under the second likely cause lot ln 06e50-68 lot 85050m500.
Patient Sequence No: 1, Text Type: N, H10
[125326042]
The customer observed false (b)(6) prism htlv results for 15 samples using 2 lots and 5 analyzers. No specific initial and repeat prism data was provided, the following samples were found (b)(6) on western blot: (b)(6). There was no impact to patient management reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1415939-2018-00148 |
| MDR Report Key | 7949050 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2018-10-09 |
| Date of Report | 2019-01-24 |
| Date of Event | 2018-06-30 |
| Date Mfgr Received | 2019-01-23 |
| Device Manufacturer Date | 2018-04-01 |
| Date Added to Maude | 2018-10-09 |
| 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 | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | NOEMI ROMERO-KONDOS, RN BSN |
| Manufacturer Street | 100 ABBOTT PARK ROAD DEPT. 09B9, LCCP1-3 |
| Manufacturer City | ABBOTT PARK IL 600643537 |
| Manufacturer Country | US |
| Manufacturer Postal | 600643537 |
| Manufacturer Phone | 224667-512 |
| Manufacturer G1 | ABBOTT LABORATORIES |
| Manufacturer Street | 100 ABBOTT PARK ROAD |
| Manufacturer City | ABBOTT PARK IL 600643500 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 600643500 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PRISM HTLV-I/HTLV-II |
| Generic Name | HTLV-I/ HTLV-II ANTIBODIES |
| Product Code | MTP |
| Date Received | 2018-10-09 |
| Catalog Number | 06E50-68 |
| Lot Number | 87063M500 |
| Device Expiration Date | 2019-05-15 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ABBOTT LABORATORIES |
| Manufacturer Address | 100 ABBOTT PARK ROAD ABBOTT PARK IL 600643500 US 600643500 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-10-09 |