MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2017-08-25 for ARCHITECT C16000 SYSTEM 03L77-01 manufactured by Abbott Manufacturing Inc.
[83683822]
An evaluation is in process. A follow-up report will be submitted when the evaluation is complete.
Patient Sequence No: 1, Text Type: N, H10
[83683823]
The customer reports falsely elevated architect clin chem phosphorus assay results being generated on an architect c16000 analyzer. A patient sample generated an initial result of 10. 1 mg/dl (customer upper normal limit is 4. 7 mg/dl). The sample retested at 3. 9 mg/dl. Controls were within specification earlier in the day. The customer discovered two bent cuvette wash nozzles and a bent r1a probe on the instrument. The customer straightened the wash nozzles and replaced the r1a probe, but failed the r1a calibration due to lls failures. A service call was initiated. No suspect results were reported from the lab. There is no impact to patient management reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1628664-2017-00322 |
| MDR Report Key | 6819880 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2017-08-25 |
| Date of Report | 2017-10-09 |
| Date Mfgr Received | 2017-10-09 |
| Device Manufacturer Date | 2009-09-01 |
| Date Added to Maude | 2017-08-25 |
| 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 | CEO |
| Date Received | 2017-08-25 |
| 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 | 2017-08-25 |
| 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 | 2017-08-25 |