FDA Adverse Event Malfunction Summary report: N

TRIAGE D-DIMER PANEL

MDR report key: 8586888 · Received May 7, 2019

Report

Report Number: 3013982035-2019-00008
Event Type: Malfunction
Date Received: May 7, 2019
Date of Event: April 8, 2019
Report Date: May 7, 2019
Manufacturer: QUIDEL CARDIOVASCULAR INC.
Product Code: GHH
PMA / PMN Number: K042890
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: UK
Reporter Occupation: OTHER HEALTH CARE PROFESSIONAL

Narratives

Additional Manufacturer Narrative · 1

INVESTIGATION CONCLUSION: THE CUSTOMER'S COMPLAINT WAS NOT REPLICATED DURING IN-HOUSE TESTING WITH RETAINS OF DEVICE LOT T10021RN. D-DIMER RECOVERY WERE OBSERVED, LOT PERFORMED PROPERLY. MANUFACTURING BATCH RECORDS FOR THE LOT WERE REVIEWED, LOT MET RELEASE SPECIFICATIONS. BASED ON THE INFORMATION AVAILABLE, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY AND NO CORRECTIVE ACTION IS REQUIRED. ALTHOUGH THIS CATALOG NUMBER (98100EU) IS NOT APPROVED IN THE UNITED STATES, THIS EVENT IS BEING REPORTED AS THE DEVICE IS SAME/SIMILAR TO CATALOG NUMBER 98100, 510(K) NUMBER K042890.

Description of Event or Problem · 1

EVENT OCCURRED IN THE (B)(6). CUSTOMER REPORTED A CORRELATION/INSTRUMENT ISSUE WITH TRIAGE D-DIMER CUT OFF POINTS COMPARED TO THE LAB'S CUT OFF POINT. PATIENT 1: (B)(6) MALE. DRAW TIME OF 9:35 ON (B)(6) 2019. TIME OF ANALYSIS IS 12:53. D-DIMER RESULTS WERE LAB ANALYZER=305 NG/ML AND TRIAGE= 239 NG/ML. LAB ANALYZER CUTOFF- 230 NG/ML. TRIAGE CUT-OFF 600 NG/ML TESTING WAS PERFORMED FOR A D-DIMER COMPARISON STUDY. UNKNOWN PATIENT OUTCOME, NO TREATMENT WAS GIVEN TO THE PATIENT BASED ON THE TRIAGE RESULTS. NO AE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
381131	TRIAGE D-DIMER PANEL	TRIAGE D-DIMER PANEL	GHH	QUIDEL CARDIOVASCULAR INC.	98100EU	T10021RN

Patients

Seq	Age	Sex	Outcome	Treatment
1	32 YR