MAUDE Adverse Event Report: BECKMAN COULTER, INC AU680 CLINICAL CHEMISTRY ANALYZER; ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE

Model Number AU681-10E

Device Problem Low Test Results (2458)

Patient Problem Misdiagnosis (2159)

Event Date 03/17/2015

Event Type  Injury  

Event Description

The customer reported obtaining erroneously low magnesium (mg) results for multiple patient samples involving the au680 clinical chemistry analyzer.Erroneous results were reported out of the laboratory.While most patients had no change to treatment, this mdr reports the event for one patient that was treated for the low mg with iv (intravenous) dose of mg.Please refer to 9612296-2015-00035, 9612296-2015-00037, and 9612296-2015-00038 for other patient treatment events.Customer indicated that controls (qc) before the event were within range, but qc after the generated low results was out of facility range low.Customer repeated all samples after troubleshooting and issued corrected reports.Au680 clinical chemistry analyzer generated multiple error flags indicating control recovery and reagent issues.There has been no report of any adverse consequences noted for this patient that was treated for the low mg results.

Manufacturer Narrative

Customer performed weekly maintenance (w2) and replaced the magnesium (mg) reagent with a fresh bottle of the same lot.The new bottle of reagent was recalibrated with no error flags or instrument alarms.Controls (qc) generated acceptable recovery within facility ranges.Customer reported that there have been no further issues with mg.Customer confirmed that no service was requested or dispatched for this event.No mechanical parts were replaced; no alignments or adjustments were needed.There have been no further issues reported.(b)(4).All associated mdrs: 9612296-2015-00035, 9612296-2015-00037, and 9612296-2015-00038.

• Brand Name: AU680 CLINICAL CHEMISTRY ANALYZER
• Type of Device: ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE
• Manufacturer (Section D): BECKMAN COULTER, INC; 250 s. kraemer blvd.; brea CA 92821
• Manufacturer (Section G): BECKMAN COULTER MISHIMA K.K.; 454-32 higashino,; nagaizumi-cho; sunto-gun, schizuoka, jp-nota 411- 0931; JA 411-0931
• Manufacturer Contact: david davis ; 250 s. kraemer blvd. m/s e1.se; brea, CA 92821 ; 7142649714
• MDR Report Key: 4687626
• MDR Text Key: 5691493
• Report Number: 9612296-2015-00036
• Device Sequence Number: 1
• Product Code: JGJ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K961274
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/17/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: AU681-10E
• Device Catalogue Number: B12188
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/17/2015
• Initial Date FDA Received: 04/14/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/01/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other