MAUDE Adverse Event Report: ABBOTT IRELAND DIAGNOSTICS DIVISION ARCHITECT TOTAL B-HCG; SYSTEM, TEST, HUMAN CHORIONIC GONADOTROPIN

Catalog Number	07K78-25
Medical Device Problem Code	False Positive Result (1227)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
An evaluation is in process.A follow up report will be submitted when the evaluation is complete.All available patient information was included.Additional patient details are not available.
Event or Problem Description
An article by jaroslav racek, ivana potocová, daniel rajdl, ladislav trefil, marie ¿olcová.¿false positive result of human chorionic gonadotropin caused by human anti-mouse antibodies¿, biochem med (zagreb) 2023;33(1):010802.The study noted false positive architect total b-hcg results (1450 u/l) on a 45-year-old woman the patient was sent to a regional hospital with the diagnosis of pregnancy of unknown localization, to exclude ectopic pregnancy.Here, due to a slight decrease in hcg concentration, she underwent a revision of her uterine cavity with a negative finding.As there was another slight decrease in the hcg concentration the next day, the uterine cavity revision was repeated and supplemented with a laparoscopic examination where the gestational sac could not be found.The patient was then transferred to a university hospital where methotrexate administration was considered.However, blood was first drawn for hcg determination: < 1 u/l (reagent kit elecsys hcg+¿b, based on electrochemiluminescence (eclia), cobas e602 analyzer (roche diagnostics) in two different samples.One of the above-mentioned samples was then sent to two other laboratories to obtain results using kits from other manufacturers.The results were 2265 u/l on an abbott architect i1000sr and 4.2 u/l using reagent kit access total beta-hcg, based on chemiluminescence (clia) on unicel dxi 800 access immunoassay system (beckman coulter).Therefore, the presence of heterophilic anti-mouse antibodies was suspected.After incubation of the sample in heterophilic blocking tubes, the hcg result was < 1.2 u/l on an abbott architect i1000sr.Therefore, pregnancy was ruled out, and the patient was discharged to home care.No additional impact to patient management was reported.
Additional Manufacturer Narrative
Data and information provided by the customer were reviewed and support the complaint issue.Manufacturing documentation for the likely cause lot did not identify any issues associated with the complaint issue.The ticket search determined that there is no increase in complaint activity for this list number.Labelling was reviewed and found to adequately address the issue under review.Interference by heterophilic antibodies was confirmed.According to the package insert heterophilic antibodies in human serum can react with reagent immunoglobulins, interfering with in vitro immunoassays.The presence of heterophilic antibodies in a patient specimen may demonstrate anomalous values.Based on the investigation no systemic issue or product deficiency was identified and the product is performing as expected.
Event or Problem Description
An article by jaroslav racek, ivana potocová, daniel rajdl, ladislav trefil, marie ¿olcová.¿false positive result of human chorionic gonadotropin caused by human anti-mouse antibodies¿, biochem med (zagreb) 2023;33(1):010802.The study noted false positive architect total b-hcg results (1450 u/l) on a 45-year-old woman the patient was sent to a regional hospital with the diagnosis of pregnancy of unknown localization, to exclude ectopic pregnancy.Here, due to a slight decrease in hcg concentration, she underwent a revision of her uterine cavity with a negative finding.As there was another slight decrease in the hcg concentration the next day, the uterine cavity revision was repeated and supplemented with a laparoscopic examination where the gestational sac could not be found.The patient was then transferred to a university hospital where methotrexate administration was considered.However, blood was first drawn for hcg determination: < 1 u/l (reagent kit elecsys hcg+b, based on electrochemiluminescence (eclia), cobas e602 analyzer (roche diagnostics) in two different samples.One of the above-mentioned samples was then sent to two other laboratories to obtain results using kits from other manufacturers.The results were 2265 u/l on an abbott architect i1000sr and 4.2 u/l using reagent kit access total beta-hcg, based on chemiluminescence (clia) on unicel dxi 800 access immunoassay system (beckman coulter).Therefore, the presence of heterophilic anti-mouse antibodies was suspected.After incubation of the sample in heterophilic blocking tubes, the hcg result was < 1.2 u/l on an abbott architect i1000sr.Therefore, pregnancy was ruled out, and the patient was discharged to home care.No additional impact to patient management was reported.

• Brand Name: ARCHITECT TOTAL B-HCG
• Common Device Name: SYSTEM, TEST, HUMAN CHORIONIC GONADOTROPIN
• Manufacturer (Section D): ABBOTT IRELAND DIAGNOSTICS DIVISION; lisnamuck; co. longford; longford N39E9 32; EI N39E932
• Manufacturer (Section G): ABBOTT IRELAND DIAGNOSTICS DIVISION; lisnamuck; co. longford; longford N39E9 32; EI N39E932
• Manufacturer Contact: nicole jenne ; max-planck-ring 2; post market surveillance; wiesbaden 65205 ; GM 65205 ; 6122582960
• MDR Report Key: 23474580
• Report Number: 3005094123-2025-00556
• Device Sequence Number: 10195760
• Product Code: DHA
• UDI-Device Identifier: 00380740014964
• UDI-Public: (01)00380740014964
• Combination Product (Y/N): N
• Initial Reporter Country: EZ
• PMA/510(K) Number: K983424
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Literature,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/25/2025

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 07K78-25
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/21/2025
• Supplement Date Received by Manufacturer: 11/25/2025
• Initial Report FDA Received Date: 11/05/2025
• Supplement Report FDA Received Date: 11/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ARC I1000SR MOD,01L86-01, SN# UNKNOWN; ARC I1000SR MOD,01L86-01, SN# UNKNOWN
• Outcome Attributed to Adverse Event: Other
• Patient Age: 45 YR
• Patient Sex: Female