MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2007-05-09 for IMX ANALYZER 1A81-20 manufactured by Abbott Diagnostics International, Ltd..
[761025]
Invalid results were obtained during the stability testing of imx theophylline reagent pack list 1a81-20, lot 41610q100. Calibration errors code 148 (polarization too small) and code 172 (calibration not accepted) were observed at test point (tp) 3 (month 9). The mp values obtained were 247. 83, 246. 61. The minimum polarization instrument specification is 250. 00. Abbott has not received any reports of adverse events related to this issue.
Patient Sequence No: 1, Text Type: D, B5
[7897641]
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
| Report Number | 2623532-2007-00004 |
| MDR Report Key | 963753 |
| Report Source | 07 |
| Date Received | 2007-05-09 |
| Date of Report | 2007-04-11 |
| Date of Event | 2007-04-03 |
| Date Mfgr Received | 2007-04-11 |
| Date Added to Maude | 2007-12-14 |
| 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 | 8479379328 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Remedial Action | RC |
| Previous Use Code | 3 |
| Removal Correction Number | 2623532-4/19/07-004-C |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | IMX ANALYZER |
| Generic Name | FPIA FOR THE QUANTITATIVE MEASUREMENT OF THEOPHYLINE IN SERU |
| Product Code | KLS |
| Date Received | 2007-05-09 |
| Model Number | NA |
| Catalog Number | 1A81-20 |
| Lot Number | 41610Q100 |
| ID Number | NA |
| Operator | NOT APPLICABLE |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 933786 |
| 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 | 2007-05-09 |