MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional report with the FDA on 2017-10-03 for ARCHITECT C16000 SYSTEM 03L77-01 manufactured by Abbott Manufacturing Inc.
[89630604]
Local phone number continued: 912699 an abbott field service engineer (fse) completed troubleshooting of the instrument. This involved removal and cleaning of waste tubing, water shock treatment to the waterbath and sample and syringe tubing were evaluated and were deemed ok. Controls and precision testing was completed and the instrument was put back into service. Review of the instrument log review was completed; from (b)(6) to (b)(6) 2017, there were 146 occurrences of error code 3375 (unable to process test, aspiration error occurred. ) tracking and trending did not identify an adverse trend for the customer issue. Labeling was reviewed and found to be adequate. Based on the available information no product deficiency of the architect c16000 analyzer, list number 03l77, was identified.
Patient Sequence No: 1, Text Type: N, H10
[89630605]
The customer generated a falsely elevated potassium result while using the architect c16000 analyzer. The customer indicated sid 0683985h generated an initial result of 6. 8 and a retest result of 4. 9 mmol/l there was no adverse impact to patient management reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1628664-2017-00368 |
| MDR Report Key | 6911988 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL |
| Date Received | 2017-10-03 |
| Date of Report | 2018-09-05 |
| Date of Event | 2017-09-10 |
| Date Mfgr Received | 2018-08-20 |
| Device Manufacturer Date | 2009-05-01 |
| Date Added to Maude | 2017-10-03 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| 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 | 224667-512 |
| 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 |
| Removal Correction Number | 1628664-07/17/18-001-C |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ARCHITECT C16000 SYSTEM |
| Generic Name | AUTOMATED CHEMISTRY ANALYZER |
| Product Code | CEM |
| Date Received | 2017-10-03 |
| Catalog Number | 03L77-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 0 |
| Device Event Key | 0 |
| Manufacturer | ABBOTT MANUFACTURING INC |
| Manufacturer Address | 1921 HURD DRIVE IRVING TX 75038 US 75038 |
| Brand Name | ARCHITECT C16000 SYSTEM |
| Generic Name | AUTOMATED CHEMISTRY ANALYZER |
| Product Code | JJE |
| Date Received | 2017-10-03 |
| 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 | 2017-10-03 |