1823260-2017-01876
Report
- Report Number
- 1823260-2017-01876
- Event Type
- Malfunction
- Date Received
- August 31, 2017
- Date of Event
- August 1, 2017
- Report Date
- October 9, 2017
- PMA / PMN Number
- K060373
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- HEALTH PROFESSIONAL
Narratives
(B)(4).
A SPECIFIC ROOT CAUSE COULD NOT BE DETERMINED AS NO PATIENT SAMPLES WERE AVAILABLE FOR INVESTIGATION. (B)(6) ASSAYS FROM DIFFERENT VENDORS USE DIFFERENT ASSAY FORMATS AND DIFFERENT ANTIGENS TO DETECT (B)(6) IGG ANTIBODIES. SINCE AN IMMUNE RESPONSE OF AN INFECTED PERSON MAY VARY, DISCREPANT RESULTS CAN BE EXPECTED DUE TO THE DIFFERENT ANTIGENS USED IN THE ASSAYS. A NEGATIVE TEST RESULT DOES NOT COMPLETELY RULE OUT THE POSSIBILITY OF AN INFECTION WITH (B)(6) AS INDIVIDUALS MAY NOT EXHIBIT ANY DETECTABLE IGG ANTIBODIES AT THE EARLY STATE OF ACUTE INFECTION. FALSE NEGATIVE RESULTS MAY OCCUR WHEN THE (B)(6) VIRUS IS GLYCOPROTEIN G (GG) DEFICIENT.
THE CUSTOMER OBTAINED QUESTIONABLE (FALSE-NEGATIVE) RESULTS FOR THREE PATIENT SAMPLES USING THE ELECSYS HSV-1 IGG IMMUNOASSAY (HSV-1) ON THE COBAS 6000 E 601 MODULE. ALL INITIAL RESULTS WERE RELEASED OUTSIDE THE LABORATORY. NO DATA FLAGS OR ALARMS OCCURRED. REFER TO THE ATTACHMENT TO THIS MEDWATCH FOR ALL PATIENT DATA. NO ADVERSE EVENTS OCCURRED. THE HSV-1 REAGENT LOT NUMBER IS 21450900 WITH AN EXPIRATION DATE OF 04/30/2018. THE CUSTOMER STATED THE LABCORP METHOD WAS FOR RESEARCH ONLY OR A LAB-DEVELOPED METHOD. THE CUSTOMER HAS STOPPED REPORTING HSV-1 RESULTS BUT CONTINUES TO RUN SAMPLES AND SEND ALIQUOTS OUT OF THE LABORATORY FOR CORRELATION. THE FIELD SERVICE REPRESENTATIVE COULD NOT FIND A CAUSE FOR THE ISSUE. HE RAN PERFORMANCE AND VOLTAGE CHECKS WHICH PASSED. THE CUSTOMER STATED THAT THERE WAS NO SAMPLE LEFT FOR INVESTIGATION. INVESTIGATION ACTIVITIES ARE ONGOING.
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 23 YR |