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 2018-09-03 for ARCHITECT CREATINE KINASE 07D63-21 manufactured by Abbott Manufacturing Inc.
[119035326]
A product recall letter was issued to all architect customers who have received architect creatine kinase, list number 07d63-21, lot number 99632un18. The letter informs the customer of the issue regarding a stability issue that may lead to quality control results shifting low out of range and/or error code 1054 "unable to calculate result, reaction check failure" for quality control and patient samples. The letter instructs the customer to discontinue use of the suspect lots and destroy any remaining inventory. The cause of the stability failure has been traced to a contamination of the bulk material.
Patient Sequence No: 1, Text Type: N, H10
[119035327]
The customer observed error code 1054 unable to calculate result, reaction check failure, for patient results when using the architect creatine kinase assay (list number 7d63, lot number 99632un18). No impact to patient management was reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1628664-2018-01758 |
| MDR Report Key | 7840603 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL |
| Date Received | 2018-09-03 |
| Date of Report | 2018-09-02 |
| Date of Event | 2018-07-26 |
| Date Mfgr Received | 2018-08-10 |
| Device Manufacturer Date | 2018-03-28 |
| Date Added to Maude | 2018-09-03 |
| 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 | OTHER HEALTH CARE PROFESSIONAL |
| 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 |
| Remedial Action | RC |
| Previous Use Code | 3 |
| Removal Correction Number | 1628664-07/19/18-002-R |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ARCHITECT CREATINE KINASE |
| Generic Name | CREATINE KINASE (CK) |
| Product Code | CGS |
| Date Received | 2018-09-03 |
| Catalog Number | 07D63-21 |
| Lot Number | 99632UN18 |
| Device Expiration Date | 2018-11-12 |
| 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 | 2018-09-03 |