MAUDE Adverse Event Report: BECKMAN COULTER ACCESS TOXO IGG REAGENT; ENZYME LINKED IMMUNOABSORBENT ASSAY, TOXOPLASMA GONDII

Catalog Number	A31588
Medical Device Problem Code	False Positive Result (1227)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/13/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer did not supply patient's age, date of birth and weight.There is no evidence that the access toxo igg reagent was returned for evaluation.A beckman coulter (bec) field service engineer (fse) was not dispatched to the customer's site in response to this event.All mdrs associated with this event are: 2122870-2016-00497, 2122870-2016-00498, 2122870-2016-00501.In conclusion, the cause of the event cannot be determined with the available information.
Event or Problem Description
The customer reported obtaining elevated toxoplasma gondii igg (access toxo igg) results for three (3) patients involving the laboratory's unicel dxi 800 access immunoassay system (serial number (b)(4)).For patient 1, the initial access toxo igg result recovered equivocal (grey zone) on (b)(6) 2016 and was discordant with the patient's clinical file and with one (1) alternate device, the vidas manufactured by (b)(4), which produced a discordant non-reactive result.The customer reanalyzed the patient's sample one (1) additional time on (b)(6) 2016 on the same laboratory's unicel dxi 800 access immunoassay system (serial number (b)(4)) and obtained one (1) non-reactive result.For patient 2, the initial access toxo igg result recovered reactive on (b)(6) 2016.The customer reanalyzed the patient's sample two (2) additional times on (b)(6) 2016 and on (b)(6) 2016 on the same laboratory's unicel dxi 800 access immunoassay system (serial number (b)(4)) and obtained two (2) reactive results.These reactive results were discordant with the patient's clinical file and with one (1) alternate device, the vidas manufactured by (b)(4), which produced a discordant non-reactive result.For patient 3, the initial access toxo igg result recovered reactive on (b)(6) 2016 and was discordant with the patient's clinical file and with one (1) alternate device, the vidas manufactured by (b)(4), which produced a discordant non-reactive result.The customer reanalyzed the patient's sample one (1) additional time on (b)(6) 2016 on the same laboratory's unicel dxi 800 access immunoassay system (serial number (b)(4)) and obtained one (1) non-reactive result.This mdr addresses the result obtained on the laboratory's unicel dxi 800 access immunoassay system (serial number (b)(4)) for patient 3.Mdr 2122870-2016-00498 addresses the results obtained on the laboratory's unicel dxi 800 access immunoassay system (serial number (b)(4)) for patient 2.Mdr 2122870-2016-00501 addresses the result obtained on the laboratory's unicel dxi 800 access immunoassay system (serial number (b)(4)) for patient 1.Calibrations, quality controls and system checks were performing within assay and instrument specifications.No hardware errors, flags or other assay issues were reported in conjunction with this event.The patient's sample was collected in a serum tube and was centrifuged at 2,000g (g-force) for ten (10) minutes at twenty (20) degrees celsius.No issues with sample integrity were reported by the customer.

• Brand Name: ACCESS TOXO IGG REAGENT
• Common Device Name: ENZYME LINKED IMMUNOABSORBENT ASSAY, TOXOPLASMA GONDII
• Manufacturer (Section D): BECKMAN COULTER; 1000 lake hazeltine drive; chaska 55318
• MDR Report Key: 6060188
• Report Number: 2122870-2016-00497
• Device Sequence Number: 360288
• Product Code: LGD
• UDI-Device Identifier: 15099590624927
• UDI-Public: (01)15099590624927(17)170515(11)NO-DATA(10)692860
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K080869
• 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): 10/03/2016

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: 05/15/2017
• Device Catalogue Number: A31588
• Device Lot Number: 692860
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/03/2016
• Initial Report FDA Received Date: 10/27/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1