MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05 report with the FDA on 2012-06-26 for ARCHITECT I2000 ANALYZER 08C89-01 manufactured by Abbott Manufacturing Inc.
[2764940]
The customer stated that a negative architect cmv igg result of 0 au/ml was reported for a patient sample on (b)(6) 2011. The sample retested positive at >250 au/ml. The initial negative result was amended. No impact to patient management was reported.
Patient Sequence No: 1, Text Type: D, B5
[10120564]
An evaluation is in process. A follow-up report will be submitted when the evaluation is complete. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[16665856]
An evaluation was performed which consisted of a review of the customer information provided, instrument service history, and a review of current architect labeling. Subsequent to the false negative result being generated, abbott field service performed multiple instrument checks as well as rerouted the pre-trigger tubing and reseated the pre-trigger valve connectors. A review of ticket history for architect (b)(4) identified no additional reports of unresolved erratic/imprecise results subsequent to field service performing multiple instrument checks, rerouting the pre-trigger tubing and reseating the pre-trigger valve connectors. Associated architect labeling addresses sample handling/sample integrity, maintenance procedures and potential causes of erratic/imprecise results on the architect i system. No adverse or non-statistical trends were identified relative to erratic results on the architect i2000. A deficiency of the architect i2000 was not identified.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1628664-2012-00322 |
| MDR Report Key | 2628177 |
| Report Source | 01,05 |
| Date Received | 2012-06-26 |
| Date of Report | 2012-05-30 |
| Date of Event | 2011-10-27 |
| Date Mfgr Received | 2012-07-23 |
| Device Manufacturer Date | 2007-08-03 |
| Date Added to Maude | 2012-10-16 |
| 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 I2000 ANALYZER |
| Product Code | OMI |
| Date Received | 2012-06-26 |
| Catalog Number | 08C89-01 |
| Operator | OTHER |
| 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 | 2012-06-26 |