MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05 report with the FDA on 2014-06-27 for ARCHITECT C16000 SYSTEM 03L77-01 manufactured by Abbott Manufacturing Inc.
[4545663]
The customer reports discrepant potassium assay results occurring intermittently since (b)(6) 2014 on the architect c16000 analyzer. One example was provided: an initial result of 6. 6 mmol/l that retested at 4. 5 mmol/l. No suspect results were reported from the lab with no patient impact. A service call was initiated.
Patient Sequence No: 1, Text Type: D, B5
[12140576]
An evaluation is in process. A follow-up report will be submitted when the evaluation is complete. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[33486915]
There were no returns made available from the customer site for this evaluation. An abbott field service engineer (fse) visited the customer site and after inspecting the analyzer identified the likely cause of the customer's issue to be the integrated chip technology (ict) pinch valve tubing, which was worn from normal use. The fse replaced the tubing. 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 system operations manual contains information to address the customer's current issue. Based on the results of the current evaluation and observations from the customer site, a product malfunction was not identified. The device performs as intended when properly maintained and sample integrity/handling is appropriate.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1628664-2014-00125 |
| MDR Report Key | 3899804 |
| Report Source | 01,05 |
| Date Received | 2014-06-27 |
| Date of Report | 2014-06-10 |
| Date of Event | 2014-06-05 |
| Date Mfgr Received | 2014-07-14 |
| Device Manufacturer Date | 2007-10-01 |
| Date Added to Maude | 2014-07-17 |
| 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 |
| Generic Name | AUTOMATED CHEMISTRY ANALYZER |
| Product Code | MZV |
| Date Received | 2014-06-27 |
| Catalog Number | 03L77-01 |
| 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 | 2014-06-27 |