MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2011-08-25 for PRISM HTLV-I/HTLV-II 06E50-68 manufactured by Abbott Laboratories.
[17923268]
The customer returned five patient samples to be used in this evaluation. Western blot testing was performed on these samples and four of the samples generated negative results while one sample generated indeterminate results (presence of p19 band). The western blot result for this discrepant sample does not meet the prism package insert criteria for interpretation as positive for anti-htlv. An evaluation of field data reported to the prism metrics database for prism htlv-i/htlv-ii reagent lot 01876m500 was next performed. (b)(4). The prism htlv-i/htlv-ii package insert (commodity number 34-6646/r04) contains information to address the customer's current issue. Based on the results of the current evaluation, the prism htlv-i/htlv-ii reagent kit lot 01876m500 is performing according to product label claims. A product deficiency was not identified.
Patient Sequence No: 1, Text Type: N, H10
[18411323]
The customer states that a sample was received for plateletpheresis from one donor and generated false (b)(6) results with the prism htlv reagent lot 01876m500 (cut-off value is 1. 00 s/co): sid: (b)(6), prism 01143, lot 01876m500, (b)(6); prism 01401: lot 01876m500, (b)(6); prism 0114, lot 01920m500, (b)(6). The issue occurred on two different prism analyzers with the same reagent lot. When the customer switched to reagent lot 01920m500, the expected (b)(6) results were generated. There is no impact to patient management reported.
Patient Sequence No: 1, Text Type: D, B5
[18743193]
An investigation is in process. A follow-up report will be submitted when the investigation is complete. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1415939-2011-00539 |
| MDR Report Key | 2223201 |
| Report Source | 05 |
| Date Received | 2011-08-25 |
| Date of Report | 2011-08-10 |
| Date of Event | 2011-08-08 |
| Date Mfgr Received | 2011-10-31 |
| Device Manufacturer Date | 2011-02-01 |
| Date Added to Maude | 2011-12-23 |
| 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 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 | 847937-512 |
| 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 |
| Product Code | MTP |
| Date Received | 2011-08-25 |
| Catalog Number | 06E50-68 |
| Lot Number | 01876M500 |
| Device Expiration Date | 2012-01-29 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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 60064350 US 60064 3500 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-08-25 |