FDA Adverse Event Malfunction Summary report: N

EPOC READER AND POWER SUPPLY

MDR report key: 12475783 · Received September 15, 2021

Report

Report Number: 3002637618-2021-00049
Event Type: Malfunction
Date Received: September 15, 2021
Date of Event: August 17, 2021
Report Date: September 15, 2021
Manufacturer: EPOCAL INC.
Product Code: CGL
UDI-DI: 00809708016685
PMA / PMN Number: K113726
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: FL, US
Reporter Occupation: OTHER HEALTH CARE PROFESSIONAL

Narratives

Additional Manufacturer Narrative · 1

SIEMENS INVESTIGATION HAS BEEN COMPLETED: THE IN-HOUSE PERFORMANCE FOR THE CARD LOT IN QUESTION, 11-21110-30, DID NOT IDENTIFY ANY PRODUCT DEFICIENCIES. WHEN THE CORRECT REFERENCE RANGES ARE APPLIED, ONLY PO2 FOR PATIENT 2 MET PSI CRITERIA IN THE CUSTOMER COMPLAINT. THEREFORE, THE INVESTIGATION FOCUSED ON THE IN-HOUSE EPOC PERFORMANCE FOR PO2. CARD LOT 11-21110-30 WAS TESTED WITH ARTERIALIZED BLOOD AND WITH AQUEOUS CONTROL FLUIDS EUROTROL L1 AND EUROTROL L3 AT THE TIME OF PRODUCT RELEASE. AQUEOUS FLUIDS AND ARTERIALIZED BLOOD DISPLAYED NO INDICATION OF DISCREPANT RESULTS AT THE TIME OF RELEASE. AQUEOUS FLUIDS EUROTROL L1 AND L3 WERE TESTED ON CARD LOT 11-21110-30 THROUGHOUT THE PRODUCT LIFETIME AND DISPLAYED NO INDICATION OF DISCREPANT RESULTS. IN ADDITION, THERE WERE NO OTHER COMPLAINTS RECEIVED ON CARD 11-21110-30. THEREFORE, THERE IS NO EVIDENCE THAT THE SYSTEM OR REAGENT CARDS ARE NOT PERFORMING AS INTENDED.

Description of Event or Problem · 1

THE CUSTOMER REPORTED A DISCREPANT HIGH PO2 RESULT ON THE EPOC WHEN COMPARED TO A PULSE OXIMETER. THERE IS NO REPORT OF INJURY DUE TO THIS EVENT.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1370048	EPOC READER AND POWER SUPPLY	EPOC READER	CGL	EPOCAL INC.	HR-1002-00-00		00809708016685

Patients

Seq	Age	Sex	Outcome	Treatment
1