MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01 report with the FDA on 2010-10-21 for ARCHITECT C8000 SYSTEM 1G06-01 manufactured by Abbott Manufacturing, Inc..
[1769416]
The customer stated falsely elevated lithium results had occurred on the architect c8000 for two patient samples. The results were reported out of the laboratory and later detected when the physicians sent repeat samples to the laboratory. Patient two of two generated an initial lithium result of 2. 540 mmol/l with a repeat result of 0. 5 mmol/l. There was no impact to patient management reported.
Patient Sequence No: 1, Text Type: D, B5
[8903046]
(b)(4). In response to this issue an investigation was initiated to further examine the customer's observation. The investigation included a review of the complaint text, a search for similar complaints, a review of labeling and a review of the service history for the analyzer in question. A review of the architect results log was completed and did not identify any issues. There were no liquid level sense logs available. The samples reported by the customer to the physicians for the extremely high lithium levels were present in the log. In addition, the calibration of the lithium assay and the controls that were run along with the calibration were reviewed. There was no repeat testing of the elevated samples at the time the high results were generated. The text of the complaint notes that physicians questioned the results and ordered additional samples. The repeat-testing sample id numbers were not available, however the repeat testing of the original samples was traced and the lower results were confirmed. The customer instituted a new laboratory practice of repeat all elevated lithium results. Product labeling was reviewed and found to adequately address probable causes and corrections for erratic results. Based on the available data, we cannot determine the exact cause of the discrepant results you saw. However, the most likely cause is some fibrin or particulates in the sample or small bubbles on the reagent surface. Either option can generate the scenario the customer observed. The customer was informed that the architect software has the capability of flagging results that are consider elevated enough to require an immediate alert to the operator. These optional parameters were not present in the customer's lithium assay configuration. Based upon the investigation, it has been determined that the architect c8000 analyzer, list number 1g06-01, (b)(4), is performing as intended. No product deficiency was identified.
Patient Sequence No: 1, Text Type: N, H10
[8920574]
(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
| Report Number | 1628664-2010-00386 |
| MDR Report Key | 1879039 |
| Report Source | 01 |
| Date Received | 2010-10-21 |
| Date of Report | 2010-10-08 |
| Date of Event | 2010-10-07 |
| Date Mfgr Received | 2010-11-10 |
| Device Manufacturer Date | 2005-11-01 |
| Date Added to Maude | 2011-07-22 |
| 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 C8000 SYSTEM |
| Generic Name | AUTOMATED CHEMISTRY ANALYZER |
| Product Code | NDW |
| Date Received | 2010-10-21 |
| Catalog Number | 1G06-01 |
| 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 | 2010-10-21 |