MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01 report with the FDA on 2007-04-10 for TDX TDXFLX METHOTREXATE II 7A12-86 manufactured by Abbott Diagnostics International, Ltd..
[18576331]
An incorrect vial order deficiency was identified for tdx/tdxflx methotrexate ii reagent list 07a121c60, lot 45050q100. The reagent bottles placed on the reagent pack were in the order s-w-t-p instead of the correct position w-s-t-p.
Patient Sequence No: 1, Text Type: D, B5
[18592915]
A digital photo of the returned kit was received from abbott. It was evaluated and found that it showed an incorrect bottle order; s-w-t-p instead of w-s-t-p per the tdxflx system operations manual. File samples of lot 45050q100 were also inspected and no discrepancy was seen in the bottles arrangement. The bottles were found correctly arranged: w-s-t-p. The internal manufacturing / production records were reviewed and a complaint tracking was performed. Although no issues were identified, the mfg history was evaluated in order to detect any event that could have caused the deficiency. It was observed that the kit packing process of the tdx/tdxflx reagents is a human dependent manual operation. Investigation of the tdx/tdxflx methotrexate ii reagent lot 45050q100 manufacturing history suggests that, at certain point during the kit packing process, the mfg operator failed to place the vials in the correct position. Testing were performed using sample kits where the s and w vials were switched from the positions w-s-t-p to s-w-t-p to resemble the defect found by the customer. Testing schemes included calibration runs and runs performed using a stored valid curve with a reagent kit having the incorrect vial order with all levels of controls (l, m, h, x, y and z). Results obtained showed similar mp values regardless of the control concentration. All the instruments used showed the same invalid results. Nevertheless, if testing is performed with a stored valid calibration curve, and no controls are run, patient results obtained could be falsely elevated or decreased. An investigation is being conducted to determine the cause of issue and address further corrective actions. This is an initial report. A final report will be issued at the conclusion of the investigation.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2623532-2007-00007 |
| MDR Report Key | 938661 |
| Report Source | 01 |
| Date Received | 2007-04-10 |
| Date of Report | 2007-03-19 |
| Date of Event | 2007-01-09 |
| Date Mfgr Received | 2007-03-19 |
| Device Manufacturer Date | 2006-10-01 |
| Date Added to Maude | 2007-11-07 |
| 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 | 3 |
| Event Location | 0 |
| Manufacturer Contact | DR. DAVID BARCH, D-09Y6, AP6C-2 |
| Manufacturer Street | 100 ABBOTT PARK ROAD |
| Manufacturer City | ABBOTT PARK IL 600646092 |
| Manufacturer Country | US |
| Manufacturer Postal | 600646092 |
| Manufacturer Phone | 8479373396 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Remedial Action | RL |
| Previous Use Code | 3 |
| Removal Correction Number | 2623532-40207-001-C |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TDX TDXFLX METHOTREXATE II |
| Generic Name | FPIA FOR THE QUANTITATIVE MEASUREMENT OF METHOTREXATE |
| Product Code | LAO |
| Date Received | 2007-04-10 |
| Returned To Mfg | 2007-01-11 |
| Model Number | NA |
| Catalog Number | 7A12-86 |
| Lot Number | 45050Q100 |
| ID Number | NA |
| Device Expiration Date | 2008-01-01 |
| Operator | UNKNOWN |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 910751 |
| Manufacturer | ABBOTT DIAGNOSTICS INTERNATIONAL, LTD. |
| Manufacturer Address | KM 58.0, CARRETERA 2 CRUCE DAVILA BARCELONETA PR 00617 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2007-04-10 |