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 2017-08-02 for ARCHITECT C16000 SYSTEM 03L77-01 manufactured by Abbott Manufacturing Inc.
[81794860]
(b)(6). The data in this report ws initially filed in manufacture report number 1415939-2017-00157, (b)(6) manufacture location was documented under the incorrect manufacture location. This report is being submitted to correct the generated manufacture report number and respective location. An investigation of the customer issue included a review of the complaint data, abbott field service representative evaluation, a device history review , instrument history review, a search for similar complaints, and a review of labeling. Return material was not available. An abbott field service engineer (fse) completed troubleshooting of the instrument. This involved completing preventative maintenance which included replacement of the which resolved the issue. The device history review did not identify any nonconformances or deviations with the bellows. The instrument history review did not identify any other complaints. Tracking and trending did not identify an adverse trend for the bellows which was replaced on the architect c16000 analyzer. Labeling was reviewed and found to be adequate. Based on the available information no product deficiency of the bellows in use on the architect c16000 analyzer, list number 03l77, was identified.
Patient Sequence No: 1, Text Type: N, H10
[81794861]
The customer observed falsely elevated lactate dehydrogenase (ldh) results for 8 patients while using the clinical chemistry ldh assay. The customer provided the following results from 06/08/2017: (b)(6). No impact to patient management was reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1628664-2017-00300 |
| MDR Report Key | 6761456 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL |
| Date Received | 2017-08-02 |
| Date of Report | 2017-08-02 |
| Date of Event | 2017-06-08 |
| Date Mfgr Received | 2017-08-02 |
| Device Manufacturer Date | 2016-02-01 |
| Date Added to Maude | 2017-08-02 |
| 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 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ARCHITECT C16000 SYSTEM |
| Generic Name | AUTOMATED CHEMISTRY ANALYZER |
| Product Code | CFH |
| Date Received | 2017-08-02 |
| 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 | 2017-08-02 |
| Catalog Number | 03L77-01 |
| 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 | 2017-08-02 |