MAUDE Adverse Event Report: BECKMAN COULTER ACCESS AFP REAGENT; KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS

Catalog Number	33211
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/16/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer did not supply patient demographics such as age, date of birth, sex or weight for the patient in question.A beckman coulter (bec) field service engineer (fse) was not dispatched for this event.There is no indication that the access afp reagent was returned to the complaint handling unit (chu) for further investigation and/or analysis.There were no reports of hardware errors, sample flags or issues with other assays in conjunction with this event.In conclusion, there was insufficient evidence supplied to reasonable suggest a cause for this event.Bec internal identifier for this event is (b)(6).
Event or Problem Description
The customer reported obtaining non-reproducible elevated alpha-fetoprotein (access afp) results for one (1) patient on the laboratory's unicel dxi 800 access immunoassay system serial number (b)(4).The patient sample in question was initially analyzed for access afp between (b)(6) 2016 and results of 69.37 ug/l to 73.42 ug/l were obtained.The initial access afp result obtained on (b)(6) 2016 was significantly lower resulting at 23.43 ug/l.The customer reanalyzed the patient's sample three (3) additional times on the same unicel dxi 800 access immunoassay system on (b)(6) 2016 and obtained non-reproducible results ranging from 25.07 ug/l to 106.81 ug/l.The non-reproducible access afp results were not released from the laboratory.There were no reports of change to patient treatment or care in conjunction with this event.The access afp assay had been calibrated on multiple occassions throughout the month of (b)(6), prior to the event.The calibrations passed within assay specifications but indicate some variations in relative light unit (rlu) recovery from calibration curve to calibration curve.One level of access afp qc (quality control) data was provided for the month of (b)(6) and demonstrated some variations in qc recovery.The customer did not supply any information regarding sample collection or processing (including centrifugation information) for the sample in question.There were no reports of sample integrity issues in conjunction with this event.

• Brand Name: ACCESS AFP REAGENT
• Common Device Name: KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS
• Manufacturer (Section D): BECKMAN COULTER; 1000 lake hazeltine drive; chaska MN 55318
• MDR Report Key: 5882216
• Report Number: 2122870-2016-00397
• Device Sequence Number: 13457410
• Product Code: LOK
• UDI-Device Identifier: H628332111
• UDI-Public: H628332111
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: P980041 S033
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/25/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/31/2017
• Device Catalogue Number: 33211
• Device Lot Number: 528691
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/25/2016
• Initial Report FDA Received Date: 08/17/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1