MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01 report with the FDA on 2012-12-26 for ARCHITECT I2000SR ANALYZER 03M74-01 manufactured by Abbott Manufacturing Inc.
[3100046]
The customer stated an architect i2000sr analyzer generated a (b)(6) result for one patient sample. The architect generated a (b)(6). The sample was retested on a vidas analyzer and a negative (b)(6) result was generated. The (b)(6) result was not reported outside the laboratory and there was no adverse impact to patient management reported.
Patient Sequence No: 1, Text Type: D, B5
[10385881]
(b)(4). A follow up report will be submitted when the evaluation is complete.
Patient Sequence No: 1, Text Type: N, H10
[15276346]
The customer stated an architect i2000sr analyzer generated a (b)(6) result for one patient sample. Further investigation of the customer issue included a review of the complaint text, a search for similar complaints, and a review of labeling. Review of the message history found multiple liquid not found and aspiration errors for the sample pipettor. Replacement of the probe resolved the issue. Tracking and trending identified no adverse trends or non-statistical trends for the probe. Labeling was reviewed and found to be adequate. No product deficiency was identified.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1628664-2012-00516 |
| MDR Report Key | 2885214 |
| Report Source | 01 |
| Date Received | 2012-12-26 |
| Date of Report | 2012-12-07 |
| Date of Event | 2012-12-06 |
| Date Mfgr Received | 2013-01-10 |
| Device Manufacturer Date | 2005-06-07 |
| Date Added to Maude | 2013-01-09 |
| 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 ROMERO-KONDOS, RN BSN |
| Manufacturer Street | 100 ABBOTT PARK ROAD DEPT. 09B9, LCCP1-3 |
| Manufacturer City | ABBOTT PARK IL 600643537 |
| Manufacturer Country | US |
| Manufacturer Postal | 600643537 |
| Manufacturer Phone | 847937-512 |
| 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 |
| Product Code | OMI |
| Date Received | 2012-12-26 |
| Catalog Number | 03M74-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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 | 2012-12-26 |