MAUDE Adverse Event Report: BECKMAN COULTER ACCESS TOTAL BHCG (5 IS); SYSTEM, TEST, HUMAN CHORIONIC GONADOTROPIN, PRODUCT CODE: DHA

Catalog Number A85264

Device Problems False Positive Result (1227); Incorrect Or Inadequate Test Results (2456)

Patient Problem Pregnancy (3193)

Event Date 10/04/2015

Event Type  Injury  

Manufacturer Narrative

The access total bhcg (5th is) reagent was not returned for evaluation.All assay verifications met specifications.Although use error may have contributed to this event, an assignable cause of the elevated access total bhcg (5th is) results cannot be determined with the information provided.All associated mdrs for this event: mdr 2122870-2015-00692, mdr 2122870-2015-00693.(b)(4).

Event Description

The customer reported obtaining elevated beta human chorionic gonadotropin (access total bhcg (5th is)) results which were obtained on the laboratory's unicel dxi 800 immunoassay system (serial number (b)(4)) for two (2) female patients.On (b)(6), 2015, the initial access total bhcg (5th is) result obtained for one patient was 6466.0 miu/ml.The following day, a second reproducible access total bhcg (5th is) result of 4748.0 miu/ml was obtained for this same first patient.Additional access total bhcg (5th is) results were also obtained as follows: 406.6 miu/ml on (b)(6), 2015 and 39.1 miu/ml on (b)(6), 2015.On (b)(6), 2015, the initial access total bhcg (5th is) result obtained for the second patient was 13779.0 miu/ml.The following day, a second access total bhcg (5th is) result of 16690.0 miu/ml was obtained for this second patient.The initial access total bhcg (5th is) results for both patients were released outside of the laboratory and the attending physicians believed that the results indicated ectopic pregnancy.Between (b)(6), 2015, the two (2) patients underwent laparoscopy procedures.During surgery it was discovered that the patients did not have ectopic pregnancies.No segments of the fallopian tubes were removed.Both patients were pregnant.Mdr 2122870-2015-00692 will address the changed to patient treatment that occurred approximately on (b)(6), 2015 for the first patient.The physicians were using the access total bhcg (5th is) assay to determine ectopic pregnancy.Per the access total bhcg (5th is) information for use (ifu), the assay is only intended for use as an aid in the early detection of pregnancy and to detect serum levels of beta human chorionic gonadotropin.It is also noted that the laboratory and the physicians were using a reference range from a previously released assay (access total bhcg).System parameters including calibration and quality control (qc) were running within and passing assay specifications.Sample collection and processing information were not provided for review.No issues with sample integrity were reported by the customer.

• Brand Name: ACCESS TOTAL BHCG (5 IS)
• Type of Device: SYSTEM, TEST, HUMAN CHORIONIC GONADOTROPIN, PRODUCT CODE: DHA
• Manufacturer (Section D): BECKMAN COULTER; 1000 lake hazeltine drive; chaska 55318
• Manufacturer (Section G): BECKMAN COULTER; 1000 lake hazeltine drive; chaska 55318
• Manufacturer Contact: jeffrey koll ; 1000 lake hazeltine drive; chaska, MN 55318 ; 9523681361
• MDR Report Key: 5193993
• MDR Text Key: 30027816
• Report Number: 2122870-2015-00693
• Device Sequence Number: 1
• Product Code: DHA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K130020
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/06/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/01/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2016
• Device Catalogue Number: A85264
• Device Lot Number: 526227
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/06/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/06/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other