MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,07 report with the FDA on 2009-12-28 for ARCHITECT I2000SR ANALYZER 3M74-01 manufactured by Abbott Manufacturing, Inc..
[1255377]
The customer stated a pregnant patient that previously tested negative for cmv igm on architect (index value of 0. 67) and vidas, generated a low reactive result (index value of 1) on the architect i2000sr analyzer with the use of reagent lot number 82373lf00. No impact to patient management was reported.
Patient Sequence No: 1, Text Type: D, B5
[8491897]
(b)(4) erratic cmv igm results. The instrument logs were not available for return. Scheduled maintenance was due on (b)(6), 2009. After maintenance procedures were performed on (b)(6), 2009, the customer issue was resolved. The current rate for the architect i2000sr erratic occurrences/million tests and complaints/million tests are below the internal rate documented at the launch for the architect i2000sr. A review of quality metrics did not identify any adverse trends related to this issue. The service history review found no additional incidents of the architect i2000sr, (b)(6), generating discrepant results or imprecise controls. Architect system operations manual (list number 201837-105) provides adequate information about troubleshooting for erratic results, operational precautions, and limitations. In the architect cytomegalovirus (cmv) igm reagent package insert (56-7560/r1), literature is provided in describing suitable specimens, results, and limitations of the procedure. Based on the available information, no product deficiency was determined. After maintenance procedures were performed, the customer issue was resolved.
Patient Sequence No: 1, Text Type: N, H10
[8502607]
(b)(4). This is an initial report. An investigation is in process. A final report will be submitted when the investigation is complete. An investigation is in process.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1628664-2009-00784 |
| MDR Report Key | 1564714 |
| Report Source | 01,07 |
| Date Received | 2009-12-28 |
| Date of Report | 2009-12-04 |
| Date of Event | 2009-12-04 |
| Date Mfgr Received | 2010-01-18 |
| Device Manufacturer Date | 2004-10-27 |
| Date Added to Maude | 2010-01-25 |
| 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 MANUFACTURING, INC. |
| Manufacturer Street | 1921 HURD DRIVE |
| Manufacturer City | IRVING TX 75038 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 75038 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ARCHITECT I2000SR ANALYZER |
| Generic Name | AUTOMATED IMMUNOASSAY ANALYZER |
| Product Code | OMI |
| Date Received | 2009-12-28 |
| Catalog Number | 3M74-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ABBOTT MANUFACTURING, INC. |
| Manufacturer Address | 1921 HURD DRIVE IRVING TX 75038 US 75038 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2009-12-28 |