MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04,05 report with the FDA on 2007-08-09 for ABBOTT HTLV-I/HTLV-II-EIA 7A92-32 manufactured by Abbott Laboratories.
[22052245]
Preliminary investigation: to troubleshoot the issue, the abbott technical specialist watched the account's fpc pipette the htlv-i/ii assay and noticed that the 5 ul sample failed the dispense into the wall and instead clung to the fpc pipette tip. The failure to dispense into the well was not flagged by the fpc, so the run was stopped manually and no data was generated. Service performed a realignment of the fpc. In a recent abbott study using the htlv-i/ii assay, the absorbance values generated when no specimen was dispensed ranged from 0. 004 to 0. 040, which demonstrated that the assay is able to produce valid results when no specimen is dispensed. The lower limit range for specimen read on the ppc is 0. 005, therefore values greater than 0. 005 fall within the valid range of the ppc. The ppc readings do not identify the missing specimen as a low invalid. Negative results are generated for wells without specimen added which could result in false negative results for positive specimens. This is an initial report. Further investigation is in process. A final report will be submitted when the investigation is completed.
Patient Sequence No: 1, Text Type: N, H10
[22185976]
The account noticed an increased number of low flags while processing the htlv-i/ii eia assay. The account stated that during the past month, every htlv-i/ii run had 3 to 22 low flags per run. The placement of the low flags has been random on the tray wells and has been seen across all commander fpc's and commander ppc's at the account. No low flags have been generated on abbott or external controls and all controls have been in range. Service was requested for the commander fpc's and commander ppc's at the account. No impact to patient management has been reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1415939-2007-00207 |
| MDR Report Key | 893438 |
| Report Source | 04,05 |
| Date Received | 2007-08-09 |
| Date of Report | 2007-07-12 |
| Date of Event | 2007-05-15 |
| Date Mfgr Received | 2007-07-12 |
| Device Manufacturer Date | 2007-03-01 |
| Date Added to Maude | 2008-02-27 |
| 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 | DR. DAVID BARCH |
| Manufacturer Street | 100 ABBOTT PARK ROAD |
| Manufacturer City | ABBOTT PARK IL 600646092 |
| Manufacturer Country | US |
| Manufacturer Postal | 600646092 |
| Manufacturer Phone | 8479379328 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ABBOTT HTLV-I/HTLV-II-EIA |
| Generic Name | EIA FOR DETECTION OF HTLV-I HTLV-II ANTIBODIES |
| Product Code | LRM |
| Date Received | 2007-08-09 |
| Model Number | NA |
| Catalog Number | 7A92-32 |
| Lot Number | 51243M200 |
| ID Number | NA |
| Device Expiration Date | 2008-01-18 |
| Operator | OTHER |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 948869 |
| Manufacturer | ABBOTT LABORATORIES |
| Manufacturer Address | 100 ABBOTT PARK ROAD ABBOTT PARK IL 600643500 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2007-08-09 |