MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2017-08-03 for ARCHITECT C4000 ANALYZER 6L45-21 02P24-40 manufactured by Abbott Manufacturing Inc.
[81813757]
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
[81813758]
The customer stated that an architect total bilirubin result of 17. 2 mg/dl was reported for a newborn patient on (b)(6) 2017. Repeat testing (per reflex rule set up by the customer) was 7. 4 mg/dl. The laboratory technician released the result of 17. 2 mg/dl without checking for the reflex result. The baby was sent to the nicu where retesting for total bilirubin was 7. 6 mg/dl. The customer is not aware of any treatment given to the baby. The repeat testing in nicu prompted the lookback at the architect results where the reflex result was discovered. No known unnecessary treatment was given and no injury was reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1628664-2017-00301 |
| MDR Report Key | 6764215 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2017-08-03 |
| Date of Report | 2018-07-31 |
| Date of Event | 2017-07-11 |
| Date Mfgr Received | 2018-07-02 |
| Date Added to Maude | 2017-08-03 |
| 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 |
| Removal Correction Number | 1628664-07/17/18-001-C |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ARCHITECT C4000 ANALYZER |
| Generic Name | AUTOMATED CHEMISTRY ANALYZER |
| Product Code | MQM |
| Date Received | 2017-08-03 |
| Model Number | 6L45-21 |
| Catalog Number | 02P24-40 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| 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 C4000 ANALYZER |
| Generic Name | AUTOMATED CHEMISTRY ANALYZER |
| Product Code | JJE |
| Date Received | 2017-08-03 |
| Model Number | 6L45-21 |
| Catalog Number | 02P24-40 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| 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 | 2017-08-03 |