MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05 report with the FDA on 2012-05-08 for ARCHITECT C16000 SYSTEM 03L77-01 manufactured by Abbott Manufacturing Inc.
[9924531]
Further investigation of the issue included a review of the complaint text, a review of the instrument by an abbott field service representative (fse), a search for similar complaints, and a review of labeling. The fse identified that the outlier results all originated from cuvette 313 on the analyser. When the cuvette was examined it was noted that it had a piece of the cuvette present, close to the lightpath beam. This piece originated from the top of cuvette and was dislodged close to the bottom internally. The cuvette was replaced on (b)(4) 2012 which corrected the issue. Tracking and trending did not identify an adverse trend. Labeling was reviewed and found to be adequate. Based on the available information a deficiency of the architect c16000 analyzer; list 3l77, was not identified.
Patient Sequence No: 1, Text Type: N, H10
[18799905]
High test results; (b)(4) no consequences or impact to patient; (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
[18844982]
The customer observed falsely elevated magnesium results for one patient. The customer provided the following results: (b)(6) 2012 (sample id (b)(6)); initial result: 6. 84 mmol/l, retest 6. 94 mmol/l, 0. 9 mmol/l. No additional patient information was provided. There was no adverse impact to patient management reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1628664-2012-00272 |
| MDR Report Key | 2564649 |
| Report Source | 01,05 |
| Date Received | 2012-05-08 |
| Date of Report | 2012-04-20 |
| Date of Event | 2012-04-18 |
| Date Mfgr Received | 2012-06-01 |
| Device Manufacturer Date | 2008-03-01 |
| Date Added to Maude | 2012-06-07 |
| 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 C16000 SYSTEM |
| Product Code | CFA |
| Date Received | 2012-05-08 |
| Catalog Number | 03L77-01 |
| Lot Number | 61466UN11 |
| 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 | 2012-05-08 |