MAUDE Adverse Event Report: BECKMAN COULTER ACCESS 2 IMMUNOASSAY ANALYZER; ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE, PRODUCT CODE: JJE

Catalog Number 81600N

Device Problem High Test Results (2457)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/29/2015

Event Type  malfunction  

Event Description

The customer reported obtaining multiple erroneous thyroglobulin antibody (access thyroglobulin antibody ii) and thyroglobulin (access thyroglobulin) results for four (4) patients on the laboratory's access 2 immunoassay system (serial number (b)(4)).The customer reanalyzed the patient's samples on the laboratory's alternate access 2 immunoassay system (serial number (b)(4)) and obtained lower results, both within the same clinical category and in different clinical categories.Initial results were reported out of the laboratory and were questioned by the physician.The samples were reanalyzed and corrected reports were sent out.The customer was unaware of change to patient treatment associated with this event.Mdr 2122870-2015-00378 will address the access thyroglobulin antibody ii and access thyroglobulin results obtained on (b)(6) 2015 for three (3) patients.Mdr 2122870-2015-00391 will address the access thyroglobulin antibody ii and access thyroglobulin results obtained on (b)(6) 2015 for two (2) patients.Mdr 2122870-2015-00392 will address the access thyroglobulin antibody ii and access thyroglobulin results obtained on (b)(6) 2015 for four (4) patients.Mdr 2122870-2015-00393 will address the access thyroglobulin antibody ii and access thyroglobulin results obtained on (b)(6) 2015 for two (2) patients.Mdr 2122870-2015-00394 will address the access thyroglobulin antibody ii and access thyroglobulin results obtained on (b)(6) 2015 for one (1) patient.Mdr 2122870-2015-00395 will address the access thyroglobulin antibody ii and access thyroglobulin results obtained on (b)(6) 2015 for five (5) patients.Mdr 2122870-2015-00396 will address the access thyroglobulin antibody ii and access thyroglobulin results obtained on (b)(6) 2015 for two (2) patients.Mdr 2122870-2015-00397 will address the access thyroglobulin antibody ii and access thyroglobulin results obtained on (b)(6) 2015 for five (5) patients.Mdr 2122870-2015-00399 will address the access thyroglobulin antibody ii and access thyroglobulin results obtained on (b)(6) 2015 for three (3) patients.Mdr 2122870-2015-00400 will address the access thyroglobulin antibody ii and access thyroglobulin results obtained on (b)(6) 2015 for one (1) patient.Mdr 2122870-2015-00401 will address the access thyroglobulin antibody ii results obtained on (b)(6) 2015 for one (1) patient.Mdr 2122870-2015-00402 will address the access thyroglobulin antibody ii and access thyroglobulin results obtained on (b)(6) 2015 for one (1) patient.Mdr 2122870-2015-00403 will address the access thyroglobulin antibody ii and access thyroglobulin results obtained on (b)(6) 2015 for eight (8) patients.Qc (quality controls), calibrations and system checks were all performing within assay and instrument specifications prior to june 3, 2015.On june 3, 2015 system check failed to meet specifications and a precision test for the access thyroglobulin antibody ii failed as all results were zero (0).The patient samples were drawn in serum tubes with and without gel separators.The samples are either drawn in-house or sent from another facility.The in-house samples are centrifuged at 3,500 revolutions per minute (rpm) at room temperature for five (5) minutes.No issue with sample integrity was reported by the customer.A beckman coulter (bec) field service engineer (fse) was dispatched to assess the analyzer.

Manufacturer Narrative

The customer did not provide patient demographics such as age, sex, date of birth or weight.A beckman coulter (bec) field service engineer (fse) was dispatched to assess the analyzer.The fse discovered foaming in the wash pump during the dispense probes prime cycle.The fse determined the foaming was due to a faulty wash valve rotor.The fse observed wear on the rotor shaft key which was causing foaming at the supply position.The rotor was replaced.After the repairs were completed, the fse performed hardware and system verification tests which passed within published performance specifications.In conclusion, the wash valve rotor was determined to be the cause of this event.All associated mdr's for this event: mdr 2122870-2015-00378, mdr 2122870-2015-00391, mdr 2122870-2015-00392, mdr 2122870-2015-00393, mdr 2122870-2015-00394, mdr 2122870-2015-00395, mdr 2122870-2015-00396, mdr 2122870-2015-00397, mdr 2122870-2015-00398, mdr 2122870-2015-00399, mdr 2122870-2015-00400, mdr 2122870-2015-00401, mdr 2122870-2015-00402, mdr 2122870-2015-00403.(b)(4).

• Brand Name: ACCESS 2 IMMUNOASSAY ANALYZER
• Type of Device: ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE, PRODUCT CODE: JJE
• 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: 4887731
• MDR Text Key: 6540286
• Report Number: 2122870-2015-00398
• Device Sequence Number: 0
• Product Code: JNL
• Reporter Country Code: US
• PMA/PMN Number: K922823/A007
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 06/03/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/02/2015
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 81600N
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/03/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/18/2012
• 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