MAUDE Adverse Event Report: CHASKA DISCRETE MFG IO ACCESS TOTAL BHCG (5TH IS); SYSTEM, TEST, HUMAN CHORIONIC GONADOTROPIN

Model Number	A85264
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	03/25/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Weight, ethnicity, race: customer did not provide patient demographics such as date of birth, weight, ethnicity or race.Device evaluated by mfr: the access total ¿hcg reagent was not returned for evaluation.A beckman coulter (bec) field service engineer (fse) was not dispatched to the customer's site.No issues with sample integrity were reported by the customer.Qc was passing within the laboratory¿s established ranges.No hardware errors or other assay issues were reported in conjunction with this event.One (1) patient sample was sent to beckman coulter for investigation.The customer result was confirmed in testing.Interference testing, using different blockers, was then carried out.This interference testing demonstrated the presence of interfering substances.In conclusion, the investigation demonstrated that an interference is the cause of the falsely elevated hcg5 results.Per the total ¿hcg instructions for use (ifu), par number (pn) b15025 e, it states: "for assays employing antibodies, the possibility exists for interference by heterophile antibodies in the patient sample.Patients who have been regularly exposed to animals or have received immunotherapy or diagnostic procedures utilizing immunoglobulins or immunoglobulin fragments may produce antibodies, e.G.Hama, that interfere with immunoassays.Additionally, other heterophile antibodies such as human anti-goat antibodies may be present in patient samples.Such interfering antibodies may cause erroneous results.Carefully evaluate the results of patients suspected of having these antibodies.Other potential interferences in the patient sample could be present and may cause erroneous results in immunoassays.Some examples that have been documented in literature include rheumatoid factor, endogenous alkaline phosphatase, fibrin, and proteins capable of binding to alkaline phosphatase.Carefully evaluate the results of patients suspected of having these types of interferences.".
Event or Problem Description
The customer reported obtaining five (5) erroneous patient results for total ¿hcg on their unicel dxi 800 access immunoassay system (s/n: (b)(4)).There was a change in patient treatment due to the elevated total ¿hcg results.The patient was operated (uterus scraping) on (b)(6) 2019 based on presentation of bleeding, hyperplasic uterus and the elevated access total ¿hcg result.The patient is a post-menopausal (b)(6) woman.

• Brand Name: ACCESS TOTAL BHCG (5TH IS)
• Common Device Name: SYSTEM, TEST, HUMAN CHORIONIC GONADOTROPIN
• Manufacturer (Section D): CHASKA DISCRETE MFG IO; 1000 lake hazeltine drive; chaska MN 55318
• MDR Report Key: 8495473
• Report Number: 2122870-2019-01068
• Device Sequence Number: 19145770
• Product Code: DHA
• UDI-Device Identifier: 15099590226213
• UDI-Public: (01)15099590226213(17)190930(11)20190930(10)871156
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K130020
• 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): 04/09/2019

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: 09/30/2019
• Device Model Number: A85264
• Device Catalogue Number: A85264
• Device Lot Number: 871156
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/25/2019
• Initial Report FDA Received Date: 04/09/2019
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 56 YR