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

Catalog Number	A85264
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/10/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer did not provide patient demographics such as age, date of birth, sex or weight.The access total bhcg (5th is) reagent was not returned for evaluation.A beckman coulter (bec) field service engineer (fse) was dispatched to assess the analyzer.The fse performed a preventative maintenance (pm), proactively replaced the sample pump and reassembled the red and white fitting tubing.The sample pump was replaced to address the pump motion failure errors that occurred four (4) to five (5) hours after this event and would not have contributed to this event.The red and white fitting tubing was also reassembled.There is insufficient evidence of a hardware or system malfunction.The assignable cause of this event is unknown and cannot be determined with the information provided.
Event or Problem Description
The customer reported obtaining a non-reproducible false low human chorionic gonadotropin (access total bhcg (5th is)) result on the unicel dxi 800 access immunoassay system (serial number (b)(4)) for a patient sample.On (b)(6) 2016, a low access total bhcg (5th is) result of 0.06 miu/ml was generated and was questioned as the result did not correlate with an access total bhcg (5th is) result of 795 miu/ml that was generated for this same patient 17 hours ago.The 0.06 miu/ml sample was repeated and a result of 759 miu/ml was generated.The sample was re-centrifuged and repeated with a result of 820 miu/ml.Results were not reported outside of the laboratory.There was no report of patient injury or change to patient treatment associated with this event.Calibration and system check were passing assay and system specifications prior to patient testing.The customer stated that controls have been recovering within the customer's established ranges.The sample was collected in a 12x75 mm serum red top tube with no gel barrier and was centrifuged at 3000 revolutions per minutes (rpms) for 10 minutes.The sample was run in an aliquot tube.The customer noted the sample was normal in appearance with no cells, no fibrin and no bubbles.A beckman coulter (bec) field service engineer (fse) was dispatched to assess the analyzer's performance.

• Brand Name: ACCESS TOTAL BHCG (5TH IS)
• Common Device Name: SYSTEM, TEST, HUMAN CHORIONIC GONADOTROPIN, PRODUCT CODE: DHA
• Manufacturer (Section D): BECKMAN COULTER; 1000 lake hazeltine drive; chaska 55318
• MDR Report Key: 6073745
• Report Number: 2122870-2016-00516
• Device Sequence Number: 13675155
• Product Code: DHA
• UDI-Device Identifier: 15099590226213
• UDI-Public: (01)15099590226213(17)170630(11)NO-DATA(10)626437
• Combination Product (Y/N): N
• Initial Reporter State: ND
• Initial Reporter Country: US
• PMA/510(K) Number: K130020
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/10/2016

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: 06/30/2017
• Device Catalogue Number: A85264
• Device Lot Number: 626437
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/10/2016
• Initial Report FDA Received Date: 11/02/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1