FDA Adverse Event Malfunction Summary report: N

1628664-2017-00363

MDR report key: 6905720 · Received September 29, 2017

Report

Report Number: 1628664-2017-00363
Event Type: Malfunction
Date Received: September 29, 2017
Date of Event: July 26, 2017
Report Date: November 8, 2017
PMA / PMN Number: K983212
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: BR
Reporter Occupation: MEDICAL TECHNOLOGIST

Narratives

Additional Manufacturer Narrative · 1

THIS ISSUE WAS PREVIOUSLY REPORTED UNDER MDR NUMBER 3005094123-2017-00050 UNDER A DIFFERENT SUSPECT MEDICAL DEVICE. AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE.

Additional Manufacturer Narrative · 1

FIELD SERVICE WAS DISPATCHED AND PERFORMED VARIOUS TROUBLESHOOTING MEASURES RELATIVE TO THE DISCREPANT B-HCG RESULTS. SERVICE REPLACED THE WASH ZONE MANIFOLD VALVES FOR BOTH WASH ZONES 1 AND 2 AND USED THE VACUUM PUMP REPAIR KIT TO REPLACE THE VACUUM PUMP DIAPHRAGMS. THE WASH ZONE MANIFOLD VALVES (PART NUMBER 7-77612-03) AND VACUUM PUMP REPAIR KIT (PART NUMBER 7-201782-01) ARE CONSIDERED TO BE THE LIKELY CAUSES. INVESTIGATION OF THE CUSTOMER ISSUE INCLUDED A REVIEW OF THE COMPLAINT TEXT, A SEARCH FOR SIMILAR COMPLAINTS AND A REVIEW OF LABELING. HISTORICAL QUALITY METRICS WERE REVIEWED AND NO ADVERSE TREND WAS IDENTIFIED. LABELING WAS REVIEWED AND FOUND TO BE ADEQUATE. BASED ON THE AVAILABLE INFORMATION, NO PRODUCT DEFICIENCY WAS IDENTIFIED.

Description of Event or Problem · 1

THE CUSTOMER STATED THAT A POSITIVE ARCHITECT TOTAL B-HCG RESULT OF 1471 MIU/ML WAS GENERATED FOR A PATIENT ON (B)(6) 2017. THE PATIENT STATED THAT SHE COULD NOT BE PREGNANT, SO THE SAMPLE WAS RETESTED AND THE ARCHITECT TOTAL B-HCG RESULT WAS NEGATIVE AT <1.2 MIU/ML. A NEW SAMPLE WAS DRAWN AND THE RESULT WAS ALSO NEGATIVE AT <1.2 MIU/ML. NO ADVERSE IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

Patients

Seq	Age	Sex	Outcome	Treatment
1