1823260-2017-01778

MDR report key: 6807478 · Received August 21, 2017

Report

Report Number: 1823260-2017-01778
Event Type: Malfunction
Date Received: August 21, 2017
Date of Event: July 25, 2017
Report Date: August 21, 2017
PMA / PMN Number: K961481
Removal / Correction Number: NA
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: BR
Reporter Occupation: OTHER HEALTH CARE PROFESSIONAL

Narratives

Additional Manufacturer Narrative · 1

(B)(6). (B)(4).

Description of Event or Problem · 1

THE CUSTOMER STATED THAT THEY RECEIVED AN ERRONEOUS RESULT FOR ONE PATIENT SAMPLE TESTED FOR ELECSYS C-PEPTIDE (CPEP) ON A ROCHE DIAGNOSTICS ELECSYS E170 MODULAR ANALYTICS IMMUNOASSAY ANALYZER (E170). THE SAMPLE INITIALLY RESULTED AS < 0.10 NG/ML AND THIS VALUE WAS REPORTED OUTSIDE OF THE LABORATORY TO THE PATIENT. THE SAMPLE WAS REPEATED AFTER A COMPLAINT WAS RECEIVED ABOUT THE INITIAL RESULT. THE SAMPLE WAS KEPT FROZEN AND THAWED BEFORE REPEATING. THE SAMPLE WAS REPEATED ON (B)(6) 2017, RESULTING AS 2.62 NG/ML. THE REPEAT VALUE WAS CONSIDERED TO BE CORRECT AND AGREED WITH THE PATIENT'S HISTORY. NO ADVERSE EVENTS WERE ALLEGED TO HAVE OCCURRED WITH THE PATIENT. THE REAGENT LOT NUMBER WAS 173976. THE REAGENT EXPIRATION DATE WAS ASKED FOR, BUT NOT PROVIDED. THE ALARM TRACE SHOWED NO RELEVANT ALARMS AROUND THE TIME THE SAMPLE WAS PIPETTED. CALIBRATION SIGNAL VALUES WERE LOWER THAN EXPECTED FOR THE LAST CALIBRATION PERFORMED ON 07/24/2017. CONTROLS WERE WITHIN RANGE ON (B)(6) 2017 AND (B)(6) 2017. A SPECIFIC ROOT CAUSE COULD NOT BE DETERMINED BASED ON THE PROVIDED INFORMATION. POSSIBLE ROOT CAUSES INCLUDE FOAM/BUBBLES ON THE SAMPLE SURFACE, A TILTED SAMPLE TUBE IN THE RACK IN COMBINATION WITH WET INNER TUBE WALLS, SAMPLE QUALITY, OR INSUFFICIENT MAINTENANCE.

Patients

Seq	Age	Sex	Outcome	Treatment
1	39 YR