MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2012-11-30 for ARCHITECT I2000SR ANALYZER 03M74-02 manufactured by Abbott Manufacturing Inc.
[2983984]
The customer observed a falsely decreased ck-mb result while using the architect i2000sr analyzer. An initial result of <0. 1 ng/ml and a retest result of 2. 1 ng/ml were generated. There was no adverse impact to patient management reported.
Patient Sequence No: 1, Text Type: D, B5
[10259441]
(b)(4). An evaluation is in process. A follow-up report will be submitted when the evaluation is complete.
Patient Sequence No: 1, Text Type: N, H10
[20901488]
Further investigation of the customer issue included a review of the complaint text, a review of the instrument service, abbott field service evaluation of the instrument, a search for similar complaints, and a review of labeling. A review of the instrument service history did not identify any additional issues. The abbott field service representative replaced the carousel gear drive. No further issues were identified after the gear was replaced. Tracking and trending did not identify an adverse trend. Labeling was reviewed and found to be adequate. Based on the available information no product deficiency of the architect 21000sr analyzer, list number 03m74, was identified.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1628664-2012-00493 |
| MDR Report Key | 2853225 |
| Report Source | 05 |
| Date Received | 2012-11-30 |
| Date of Report | 2012-11-15 |
| Date of Event | 2012-11-15 |
| Date Mfgr Received | 2013-01-16 |
| Device Manufacturer Date | 2010-08-27 |
| Date Added to Maude | 2013-02-25 |
| 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 | 0 |
| 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 | JLB |
| Date Received | 2012-11-30 |
| Catalog Number | 03M74-02 |
| 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 | 2012-11-30 |