MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01 report with the FDA on 2010-12-29 for ARCHITECT I2000SR ANALYZER 3M74-01 manufactured by Abbott Manufacturing, Inc..
[1749343]
The customer states that (b)(6) results have been generated with the architect cmv igm assay. One patient generated a (b)(6) index result that tested at a negative index result on a non-abbott platform. Controls have remained within specifications. No suspect results have been reported from the lab. There is no impact to patient management reported. A service call was initiated.
Patient Sequence No: 1, Text Type: D, B5
[8805664]
(b)(4). An investigation is in process. A follow-up report will be submitted when the investigation is complete.
Patient Sequence No: 1, Text Type: N, H10
[15166171]
(b)(4). An abbott field service representative (fsr) was dispatched to the customer site and found that the sample probe was loose and that buffer build up was present on both wash zones. The fsr replaced and calibrated the sample, stat, reagent 1 and reagent 2 probes. Additionally, the fsr replaced both wash zone manifolds. The fsr indicates that the replacement of the components resolved the issue and that the instrument is performing according to specifications. The architect system operations manual (pn 201837-108), january 2010 and the architect cmv igm assay package insert ((b)(4)) contain information to address the customer's current issue. A review of complaint tracking and trending metrics was performed and identified no adverse trends in conjunction with the complaint issue currently under evaluation. Review of complaint tracking and trending; field service intervention.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1628664-2010-00512 |
| MDR Report Key | 1940916 |
| Report Source | 01 |
| Date Received | 2010-12-29 |
| Date of Report | 2010-12-22 |
| Date Mfgr Received | 2011-01-18 |
| Device Manufacturer Date | 2005-06-07 |
| Date Added to Maude | 2011-12-23 |
| 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 | 2010-12-29 |
| 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 | 2010-12-29 |