FDA Adverse Event Malfunction Summary report: N

AIA-360

MDR report key: 7340513 · Received March 14, 2018

Report

Report Number: 8031673-2018-01276
Event Type: Malfunction
Date Received: March 14, 2018
Date of Event: March 30, 2017
Report Date: March 14, 2018
Manufacturer: TOSOH CORPORATION
Product Code: KHO
PMA / PMN Number: K971103
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: AZ, US
Reporter Occupation: HEALTH PROFESSIONAL

Narratives

Additional Manufacturer Narrative · 0

THE COMPLAINT WAS DISPATCHED TO THE FIELD SERVICE ENGINEER (FSE) DEPARTMENT ON THE (B)(6) 2017 FOR FURTHER INVESTIGATION. THE FSE CONDUCTED A FOLLOW-UP WITH THE CUSTOMER OVER-THE-PHONE TO ADDRESS THE REPORTED EVENT. DURING THE INVESTIGATION THE FSE CONFIRMED WITH THE CUSTOMER PROPER SHUTDOWN OF INSTRUMENT AT THE END OF THE DAY. PER REQUEST OF THE FSE THE CUSTOMER PERFORMED THE DECONTAMINATION PROCEDURE ON THE INSTRUMENT AND THEN THEY RAN CALIBRATORS AND QUALITY CONTROL. ALL RESULTS WERE WITHIN RANGE, THE INSTRUMENT IS FUNCTIONING AS INTENDED AND WAS RELEASED. THE MOST PROBABLE CAUSE FOR THIS EVENT IS CONTAMINATION OF THE DEVICE. TOSOH BIOSCIENCE, INC. IS SUBMITTING ON BEHALF OF THE FOREIGN MANUFACTURER, TOSOH CORPORATION, PER EXEMPTION NUMBER E2017013. THIS REPORT IS BEING SUBMITTED DUE TO A RETROSPECTIVE REVIEW CONDUCTED UNDER CAPA (B)(4).

Description of Event or Problem · 0

ON THE (B)(6) 2017 THE CUSTOMER REPORTED FREE T4 LOT# G917518 CONTROL IMPRECISION. CUSTOMER INDICATED THAT THEY ARE USING CALIBRATOR LOT G934610. THEY RAN BIO RAD LOT 40330 AND THE RESULTS WERE AS FOLLOW: RANGE, RESULT: LEVEL 1 0.57-1.06, 0.590, 0.850; LEVEL 2 1.84-3.42, 1.790 OUT OF RANGE, 2.65; LEVEL 3 4.32->8 , 5.830, 5.70 . LEVEL 1 AND 3 ARE WITHIN RANGE BUT LEVEL 2 WAS OUT OF RANGE. ALSO, THE PHYSICIAN INDICATED THE PATIENT RESULTS HAVE BEEN LOW.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
182580	AIA-360	AIA-360	KHO	TOSOH CORPORATION	AIA-360

Patients

Seq	Age	Sex	Outcome	Treatment
1