MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01 report with the FDA on 2011-09-07 for ARCHITECT I2000SR ANALYZER 03M74-95 manufactured by Abbott Manufacturing Inc.
[2382402]
The customer observed false positive results for a patient that tested architect cmv igg positive at 6. 4 au/ml on (b)(6), 2011. A new sample from this patient was tested on (b)(6) 2011 and the result was negative at 0. 4 au/ml. The sample from (b)(6) was thawed, recentrifuged and retested with a negative cmv igg result and positive cmv igm result. The cmv igm result retested negative. Sample for this patient was sent to another laboratory for testing and both cmv igg and cmv igm results were negative. No impact to patient management was reported.
Patient Sequence No: 1, Text Type: D, B5
[9389778]
An abbott field service engineer performed preventive maintenance on the architect ci2000sr which included replacement of multiple parts. After replacing and/or exchanging the parts, there was no reoccurrence of false (b)(4) results. The architect system operations manual, section 10 troubleshooting and diagnostics, provides adequate probable causes for erratic assay results. A single definitive cause for the customer's issue could not be determined as multiple parts were replaced through preventive maintenance. A deficiency of the architect system was not identified.
Patient Sequence No: 1, Text Type: N, H10
[9463014]
An evaluation is in process. A follow-up report will be submitted when the evaluation is complete. No consequences or impact to patient. Incorrect or inadequate test result.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1628664-2011-00600 |
| MDR Report Key | 2237433 |
| Report Source | 01 |
| Date Received | 2011-09-07 |
| Date of Report | 2011-08-11 |
| Date of Event | 2011-07-27 |
| Date Mfgr Received | 2011-10-25 |
| Device Manufacturer Date | 2006-10-25 |
| Date Added to Maude | 2011-10-21 |
| 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 | 2011-09-07 |
| Catalog Number | 03M74-95 |
| 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 | 2011-09-07 |