MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2011-06-09 for SYNCHRON CX4/CX5 CLINICAL CHEMISTRY ANALYZER REAGENT 476826 manufactured by Beckman Coulter, Inc..
[2055689]
A customer reported that erroneously low alanine transaminase (alt) results were generated from a unicel dxc 600 synchron system upon the usage of a newly installed synchron cx4/cx5 clinical chemistry analyzer alt reagent kit. The customer was advised to prepare a new alt reagent kit and rerun the suspect results for the event timeframe. The customer repeated the questionable samples on a second instrument. Out of 15 suspect patient sample results, three were identified as erroneous based upon repeat test results. The initial, erroneous alt results were generated on a single, overnight shift spanning (b)(6) 2011 and (b)(64) 2011. No erroneous results were reported out of the laboratory and hence there was no death, serious injury or modification to patient treatments associated or attributed to this event.
Patient Sequence No: 1, Text Type: D, B5
[9130532]
Service was not dispatched as the root cause was identified during beckman coulter inc. Customer technical service troubleshooting via phone. Investigation revealed that the customer had not prepared the synchron cx4/cx5 clinical chemistry analyzer alt reagent kit correctly. They had not transferred the a-reagent bottle into compartment a of the reagent cartridge. The instructions for use, which describe how to prepare the reagent kit were present in the reagent kit packaging.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2050012-2011-02123 |
| MDR Report Key | 2119205 |
| Report Source | 05,06 |
| Date Received | 2011-06-09 |
| Date of Report | 2011-05-14 |
| Date of Event | 2011-05-13 |
| Date Mfgr Received | 2011-05-14 |
| Device Manufacturer Date | 2010-09-27 |
| Date Added to Maude | 2012-02-23 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | MS NORA ZEROUNIAN |
| Manufacturer Street | 250 S KRAEMER BLVD. |
| Manufacturer City | BREA CA 92821 |
| Manufacturer Country | US |
| Manufacturer Postal | 92821 |
| Manufacturer Phone | 7149613634 |
| Manufacturer G1 | BECKMAN COULTER, INC. |
| Manufacturer Street | 250 S KRAEMER BLVD. |
| Manufacturer City | BREA CA 92821 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 92821 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SYNCHRON CX4/CX5 CLINICAL CHEMISTRY ANALYZER REAGENT |
| Generic Name | NADH OXIDATION/NAD REDUCTION, ALT/SGPT |
| Product Code | CKA |
| Date Received | 2011-06-09 |
| Model Number | NA |
| Catalog Number | 476826 |
| Lot Number | M008719 |
| ID Number | NA |
| Device Expiration Date | 2012-03-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BECKMAN COULTER, INC. |
| Manufacturer Address | 250 S KRAEMER BLVD. BREA CA 92821 US 92821 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-06-09 |