MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2017-03-06 for ARCHITECT C16000 SYSTEM 03L77-01 manufactured by Abbott Manufacturing Inc.
[69208672]
An evaluation is in process. A follow-up report will be submitted when the evauation is complete.
Patient Sequence No: 1, Text Type: N, H10
[69208673]
The customer experienced falsely elevated bilirubin results for one patient while using the architect c16000 analyzer. The following data was provided. Initial 8. 6 mg/dl; expected result was 0. 9 mg/dl. No impact to patient management was reported.
Patient Sequence No: 1, Text Type: D, B5
[73134400]
The abbott field service representative (fsr) was dispatched to the account after the customer replaced the damaged reagent probe (part 09d48-02) and confirmed the damaged probe. The fsr also found the cuvette drying tips were damaged when the probe was replaced and the cuvette washer was clogged by a piece of the drying tip. Evaluation of the customer issue included a review of the complaint text, a search for similar complaints, labeling review, a device history review, and an instrument service review. No returns were made available from the customer site for this evaluation. No adverse trend was identified for the customer issue. Labeling was reviewed and found to be adequate. Device history review did not identify any issues that may have caused the customer issue. The issue was resolved and the analyzer was returned to service. Service history review identified no contributing factors to the customer issue. Based on all available information and abbott diagnostics complaint investigation, the device did not perform as intended. A malfunction of the reagent probe (part 09d48-02) was identified. No product deficiency was identified.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1628664-2017-00055 |
| MDR Report Key | 6382037 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2017-03-06 |
| Date of Report | 2017-04-07 |
| Date Mfgr Received | 2017-03-27 |
| Device Manufacturer Date | 2008-02-01 |
| Date Added to Maude | 2017-03-06 |
| 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 | MQM |
| Date Received | 2017-03-06 |
| Catalog Number | 03L77-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| 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 | 2017-03-06 |
| 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 | 2017-03-06 |