MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2013-11-27 for UNICEL? DXC 600 SYNCHRON? SYSTEM A11810 manufactured by Beckman Coulter.
[4043110]
The customer reported approximately 40 erroneous high test patient results for hemoglobin a1c (hba1c-) when using the unicel dxc 600 synchron system. Erroneous high test results were reported out of the laboratory. Reruns on another dxc generated lower acceptable results and were amended. Some of the 40 patients were treated with anti-diabetic medication. Medication was suspended after the amended results were provided. Customer received no reports of any adverse affect to patients after medication was administered and then later suspended.
Patient Sequence No: 1, Text Type: D, B5
[11295870]
The customer identified the failure mode as use error. Customer noted their quality control (qc) results were trending up high prior to this patient event and were ignored. No calibration or qc data was provided for review. On (b)(6) 2013, the customer stated there was no issue with the dxc instrument or the assay reagent. Customer claimed to resolve the issue on their own and no service call was initiated or generated. Product labeling review: per hba1c- cis labeling b04787ac (b)(6) 2013: if running the hba1c assay in random access, cuvette cleaning procedure with cartridge chemistry wash solution (ccwa, pn 657133) is recommended weekly. The cuvette cleaning procedure can be conducted by selecting the "cc cuvettes" when performing the automated maintenance procedure #10 "clean flow cell, cups, & cc probes/mixers". If running the hba1c assay in batch mode from standby, the automated maintenance procedure #9 "cc reagent wash all cuvettes" is recommended after every 4th batch of hba1c. This cuvette cleaning procedure is required to minimize the risk of cuvette coating by the hba1c- reagent. If unacceptable drift or imprecision is observed in quality control results or calibration failures are observed, additional cuvette cleaning is recommended. Additional cuvette cleaning can be conducted using procedure #10 as described above or by choosing the automated maintenance procedure #9 "cc reagent wash all cuvettes". Identified failure mode: use error. There is evidence to suggest that the customer was not cleaning the cuvettes as frequently as bec recommends in the product labeling to avoid this type of qc and patient situation per hba1c- cis labeling b04787ac (b)(6) 2013.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2050012-2013-00782 |
| MDR Report Key | 3490689 |
| Report Source | 05,06 |
| Date Received | 2013-11-27 |
| Date of Report | 2013-11-05 |
| Date of Event | 2013-11-04 |
| Date Mfgr Received | 2013-11-05 |
| Device Manufacturer Date | 2007-02-07 |
| Date Added to Maude | 2013-11-27 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | MS. DUNG NGUYEN |
| Manufacturer Street | 250 S KRAEMER BLVD |
| Manufacturer City | BREA CA 92821 |
| Manufacturer Country | US |
| Manufacturer Postal | 92821 |
| Manufacturer Phone | 7149614941 |
| Manufacturer G1 | BECKMAN COULTER |
| 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 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | UNICEL? DXC 600 SYNCHRON? SYSTEM |
| Generic Name | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE |
| Product Code | PDJ |
| Date Received | 2013-11-27 |
| Model Number | NA |
| Catalog Number | A11810 |
| Lot Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BECKMAN COULTER |
| Manufacturer Address | 250 S. KRAEMER BLVD. BREA CA 92821 US 92821 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2013-11-27 |