MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-05-03 for ARCHITECT C16000 SYSTEM 03L77-01 manufactured by Abbott Manufacturing Inc.
[44615141]
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
[44615142]
The customer reports falsely elevated clin chem total bilirubin assay results generated on four pediatric patient samples tested on an architect c16000 analyzer (sn: (b)(4)). The following was provided (results in mg/dl): patient #1: 19. 9 and retested on a second analyzer in the lab = 2. 1. Patient #2: 10. 3 and retested on a second analyzer in the lab = 0. 3. Patient #3: 6. 5 and retested on a second analyzer in the lab = 1. 4. Patient #4: 12. 8 and retested on a second analyzer in the lab = 0. 5. (the second analyzer is an architect c8000 analyzer, sn: (b)(4)). This customer uses a normal reference range of 0. 1 - 1. 0 mg/dl. No suspect results were reported from the lab with no reported patient impact. The customer has taken this analyzer offline and is requesting a service call.
Patient Sequence No: 1, Text Type: D, B5
[46297980]
An abbott field service representative (fsr) visited the customer site and replaced the sample probe. The fsr indicated the sample probe was damaged and determined the probe as the likely cause for the customer issue. There have been no additional discrepant results reported on this architect c16000 analyzer (sn: (b)(4)) since the sample probe was replaced. Instrument operations have been 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 provides information to address the current customer issue. Based on the available information from the customer site and from the results of this evaluation, there is no evidence to reasonably suggest a product malfunction occurred. The issue was addressed through standard troubleshooting procedures.
Patient Sequence No: 1, Text Type: N, H10
[73134079]
The device evaluation was reassessed and concluded that a malfunction occurred; therefore, the device was not performing as intended and the evaluation codes were corrected.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1628664-2016-00119 |
| MDR Report Key | 5628948 |
| Date Received | 2016-05-03 |
| Date of Report | 2017-04-07 |
| Date Mfgr Received | 2017-04-07 |
| Device Manufacturer Date | 2008-02-01 |
| Date Added to Maude | 2016-05-03 |
| 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 | 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 | JFM |
| Date Received | 2016-05-03 |
| 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 | 2016-05-03 |
| 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 | 2016-05-03 |