MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2009-09-16 for PRISM HTLV-I/HTLV-II 6E50-68 manufactured by Abbott Laboratories.
[1229593]
The customer stated they have observed an increase in repeat reactive rates on the prism htlv i/ii assay. The samples were from a normal donor population and did not confirm by supplemental testing performed at a reference laboratory. No impact to patient management was reported.
Patient Sequence No: 1, Text Type: D, B5
[1432777]
Same patient as: 2134265-2010-02328, 2134265-2010-04245, 2134265-2010-04151. It was reported that post a stenting treatment procedure, a patient death occurred. Lesions were located in the left circumflex artery to the first obtuse marginal artery and the right coronary artery. A greater than 75% stenosed lesion was located in a non-calcified and tortuous proximal left circumflex artery. As the physician was attempting to pull the 182cm luge guidewire into a q-curve guide catheter, it was noted that the end of the wire had appeared to loop back on itself. The physician felt a slight catch and approximately 40mm of the distal portion of the luge guidewire sheared off in the proximal left circumflex artery into the left main artery. A snare was used in an attempt to remove the fractured wire, but was unsuccessful. A 3. 0x20mm veriflex stent was then deployed in the left circumflex artery to cover the wire. Three additional stents were also placed in the procedure; a 2. 75x16mm taxus liberte' stent was placed in the right coronary artery, a 2. 5x12mm taxus liberte' stent was placed in the distal left circumflex artery, and a 3. 0x16mm taxus liberte' stent was placed in the first obtuse marginal artery. It is unknown if the stents in the left circumflex artery to first obtuse marginal artery were overlapping, but they were noted to be in close proximity. No further patient complications were reported. Patient's status was listed as okay. Four months post procedure, the patient expired. An autopsy found thrombus in the left circumflex artery in the proximity of the veriflex stent. No thrombus was noted in the right coronary artery. The patient was prescribed effient, but it is unknown if the patient was compliant with their medication at the time of their death.
Patient Sequence No: 1, Text Type: D, B5
[8412232]
(b) (4) 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
[8504916]
(b)(4). Field data related to the quality issue within the complaint (elevated reactive rates) from multiple customers and reagent kits from lot 74602m100 were reviewed in this investigation. A review of field data was performed. Initial and repeat reactive rates for lot 74602m100 was compared to the upper 95% confidence limits in the prism htlv-i/htlv-ii package insert (commodity (b)(4)) for the combined serum/plasma population, as well as for the serum population. A product deficiency has been identified in that prism htlv-i/htlv-ii reagent kit list 06e50-68 lot 74602m100 has exhibited a repeat reactive rate with a serum population that was greater than the package insert upper 95% confidence limit. An investigation has been initiated to determine cause. A final report will be submitted when the investigation is complete.
Patient Sequence No: 1, Text Type: N, H10
[8757668]
(b)(4) - reactivity originating from htlv-i viral lysate. Thirty of 79 prism htlv-i / htlv-ii reagent lots, list number 06e50-68, have exhibited initial reactive rates (irr) and/or repeat reactive rates (rrr) that exceed the package insert 95% confidence interval upper limit. Multiple customer complaints related to reactive rates from several sites representing various geographic areas for these lots have been received since 7/30/08. There was no impact to product functionality or product performance. The probable cause of some reagent lots exhibiting irr and/or rrr that exceed the package insert 95% confidence interval upper limit is that these clinical results were obtained from the 3 clinical lots combined and does not accurately represent the individual clinical lot irr and rrr performance. A contributing factor for the higher than expected repeat reactive rates observed at multiple customer sites for the prism htlv-i/htlv-ii assay is a sample-specific antibody interaction with the microparticle and probe components of the assay reagents. The target of this reactivity originates from the htlv-i viral lysate.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1415939-2009-01111 |
| MDR Report Key | 1473847 |
| Report Source | 07 |
| Date Received | 2009-09-16 |
| Date of Report | 2009-08-21 |
| Date of Event | 2009-07-29 |
| Date Mfgr Received | 2010-08-17 |
| Device Manufacturer Date | 2009-03-30 |
| Date Added to Maude | 2010-09-13 |
| 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 | 2009-09-16 |
| Catalog Number | 6E50-68 |
| Lot Number | 74602M100 |
| Device Expiration Date | 2010-04-01 |
| 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 | 2009-09-16 |