FDA Adverse Event Malfunction Summary report: N

ELECSYS FSH

MDR report key: 22086907 · Received May 27, 2025

Report

Report Number: 1823260-2025-01602
Event Type: Malfunction
Date Received: May 27, 2025
Date of Event: May 2, 2025
Report Date: June 27, 2025
Manufacturer: ROCHE DIAGNOSTICS
Product Code: CGJ
UDI-DI: 07613336170373
PMA / PMN Number: EXEMPT
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: IN
Reporter Occupation: OTHER HEALTH CARE PROFESSIONAL
Health Professional: Yes

Narratives

Additional Manufacturer Narrative · 0

SECTION D4 WAS UPDATED. CORRECTION: THE COBAS 6000 CORE UNIT E601 MODULE SERIAL NUMBER WAS (B)(6) INSTEAD OF (B)(6). THE CALIBRATION FOR LOT NUMBER 850527 WAS WITHIN EXPECTATION. THE CHART SHOWED THAT THE CALIBRATION BEFORE THAT HAD SOME ISSUES. A GENERAL REAGENT OR ANALYZER PROBLEM CAN BE EXCLUDED BECAUSE THE QC PRIOR TO THE EVENT WAS WITHIN RANGES. THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED.

Additional Manufacturer Narrative · 0

THE FSH REAGENT EXPIRATION DATE WAS NOT PROVIDED. THE COBAS 6000 CORE UNIT SERIAL NUMBER WAS (B)(6). THE QC WAS WITHIN THE ASSIGNED RANGES ON THE DAY OF THE EVENT. THE INVESTIGATION IS ONGOING.

Description of Event or Problem · 0

WE RECEIVED AN ALLEGATION ABOUT DISCREPANT RESULTS FOR 1 PATIENT SAMPLE TESTED WITH ELECSYS FOLLICLE STIMULATING HORMONE (FSH) ASSAY ON A COBAS 6000 CORE UNIT. INITIAL RESULT: 7.52 MIU/ML. THE PHYSICIAN QUESTIONED THE INITIAL RESULT AS IT DID NOT MATCH THE PATIENT'S PREVIOUS RESULTS. REPEAT RESULT: 19.10 MIU/ML. THE REPEAT RESULT WAS DEEMED TO BE CORRECT.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
728886	ELECSYS FSH	RADIOIMMUNOASSAY, FOLLICLE-STIMULATING HORMONE	CGJ	ROCHE DIAGNOSTICS		766224	07613336170373

Patients

Seq	Age	Sex	Outcome	Treatment
1	NA	Unknown