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

Model Number	34470
Medical Device Problem Code	False Positive Result (1227)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	09/08/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient demographics such as age, date of birth, weight, race and ethnicity were not supplied.(b)(6).A beckman coulter (bec) field service engineer (fse) was not dispatched to the customer's laboratory to assess instrument performance as the customer was not questioning the performance in conjunction with this event.System parameters, including quality controls (qc) and calibrations were performing with instrument specifications at the time of the event.The access toxo igm reagent was not returned to bec for further investigation.No further information is available regarding the performance of the reagent.There were no reports of error messages, system flags or issues with other patients/assays in conjunction with this event.In conclusion, the cause of the reproducible, reactive access toxo igm results could not be determined with the information supplied.
Event or Problem Description
The customer reported obtaining a reproducible reactive toxoplasmosis gondii igm (access toxo igm) result for one pregnant female (1) patient on the laboratory's access 2 immunoassay system (serial number (b)(4)).The customer reanalyzed the patient's sample on the same access 2 immunoassay system two (2) additional times using new samples each time and obtained reactive results.The patient's toxoplasmosis gondii igg (access toxo igg) results were all non-reactive.Therefore, the access toxo igm results were in question by the physician.The initial, reactive access toxo igm result was reported outside the laboratory.The patient was then administered an antibiotic due to the reactive access toxo igm result obtained.The exact antibiotic was not named by customer.Quality control (qc) and calibrations were performing within assay and instrument specifications at the time of the event.No errors were posted to the instrument's event log in conjunction with this event.The customer did not provide sample collection and processing information such as tube type, centrifugation time and centrifugation speed.

• Brand Name: ACCESS TOXO IGM REAGENT
• Common Device Name: ENZYME LINKED IMMUNOABSORBENT ASSAY, TOXOPLASMA GONDII
• Manufacturer (Section D): BECKMAN COULTER; 1000 lake hazeltine drive; chaska MN 55318
• MDR Report Key: 7922857
• Report Number: 2122870-2018-01019
• Device Sequence Number: 1437845
• Product Code: LGD
• UDI-Device Identifier: 15099590624804
• UDI-Public: (01)15099590624804(17)190222(11)180222(10)891223
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• PMA/510(K) Number: K003259
• 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): 10/01/2018

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 02/22/2019
• Device Model Number: 34470
• Device Catalogue Number: 34770
• Device Lot Number: 891223
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 09/21/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/21/2018
• Initial Report FDA Received Date: 10/01/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other