MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05 report with the FDA on 2014-01-08 for ARCHITECT C8000 SYSTEM 01G06-01 manufactured by Abbott Manufacturing Inc.
[15807849]
The customer reports a falsely elevated architect potassium assay result generated on an architect c8000 analyzer. An initial result of 9. 5 mmol/l was generated that retested into the normal reference range (3. 5 - 5. 1 mmol/l). Controls had been within specification at the beginning of the run. The sample was drawn into a lithium heparin collection tube. The customer recalibrated the integrated chip technology (ict) module and reran controls, which remained within specifications. There were no issues with any other electrolytes. The customer service consultant (csc) advised the customer to replace the ict module, which was beyond warranty. The customer requested a service visit. No suspect results were reported from the lab with no patient impact.
Patient Sequence No: 1, Text Type: D, B5
[15983314]
An abbott field service representative (fsr) visited the customer site and found a bent r1 reagent probe. The fsr replaced the probe. Subsequent instrument operations and test results were acceptable. A review of complaint tracking and trending metrics was performed and identified no adverse trends in conjunction with the complaint issue currently under evaluation. The architect systems operations manual contains information to address the current customer issue. Based on the information provided and the results of the current evaluation, a product malfunction was not identified. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1628664-2014-00004 |
| MDR Report Key | 3562842 |
| Report Source | 01,05 |
| Date Received | 2014-01-08 |
| Date of Report | 2013-12-23 |
| Date of Event | 2013-12-23 |
| Date Mfgr Received | 2013-12-23 |
| Device Manufacturer Date | 2006-01-01 |
| Date Added to Maude | 2014-03-05 |
| 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 |
| Reporter Occupation | MEDICAL TECHNOLOGIST |
| 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 C8000 SYSTEM |
| Product Code | MZV |
| Date Received | 2014-01-08 |
| Catalog Number | 01G06-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| 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 | 2014-01-08 |