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

Model Number AU681-10DE, WIN7, CHEMISTRY ANALYZER AU680 FOR DIRECT TRACK

Device Problem High Test Results (2457)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/17/2018

Event Type  Injury  

Manufacturer Narrative

A beckman coulter (bec) field service engineer (fse) was sent to the customer site.The fse recalibrated and redirected qc.The patient sample was rerun on a different instrument.No system or equipment malfunction was identified and no parts were replaced.Beckman coulter internal identifier is case-(b)(4).

Event Description

The customer reported the au680 clinical chemistry analyzer generated an erroneously high procalcitonin (pct) patient result.The result was released from the lab and the patient was prescribed an antibiotic, augmentin, as a result of the erroneously high pct result.The patient was later released from hospital and no patient harm was reported.

• Brand Name: AU680 CLINICAL CHEMISTRY ANALYZER
• Type of Device: ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE
• Manufacturer (Section D): BECKMAN COULTER; 250 s. kraemer blvd; brea CA 92821 8000
• Manufacturer (Section G): BECKMAN COULTER MISHIMA K.K.; 454-32 higashino; nagaizumi-cho sunto-gun JP-NO TA 4; JA JP-NOTA 41
• Manufacturer Contact: david davis ; 250 s. kraemer blvd; brea, CA 92821-8000 ; 7149613796
• MDR Report Key: 8072199
• MDR Text Key: 127207591
• Report Number: 9612296-2018-01095
• Device Sequence Number: 0
• Product Code: PRI
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K961274
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/14/2018
• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Model Number: AU681-10DE, WIN7, CHEMISTRY ANALYZER AU680 FOR DIRECT TRACK
• Device Catalogue Number: B96695
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 10/18/2018
• Date Manufacturer Received: 10/18/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2017
• 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