FDA Adverse Event Malfunction Summary report: N

(COC/AMP/EDDP100/MOP/BZO)MULTI-DRUG ONE STEP 5 DRUG SCREEN TEST PANEL (URINE)

MDR report key: 5287610 · Received December 10, 2015

Report

Report Number: 2027969-2015-01002
Event Type: Malfunction
Date Received: December 10, 2015
Date of Event: August 1, 2015
Report Date: November 16, 2015
Product Code: DIO
PMA / PMN Number: K061718
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: GM
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

THE PRODUCT CODE FOR BENZODIAZEPINE IS NOT LISTED; IT IS JXM. CUSTOMER'S OBSERVATION WAS NOT REPLICATED IN-HOUSE WITH RETENTION DEVICES. RETENTION (N=29) DEVICES WERE TESTED WITH IN-HOUSE DRUG FREE DONOR URINE; ALL RESULTS WERE (B)(6) AT READ TIME. NO COC/BZO (B)(6)WERE OBTAINED. MANUFACTURING BATCH RECORD REVIEW DID NOT UNCOVER ANY ABNORMALITIES. PER ISSUE, PATIENT WAS TAKING IBUPROFEN, ACCORDING TO THE CROSS-REACTIVITY LIST FOR THE PRODUCT; IBUPROFEN DOES NOT REACT WITH BZO ASSAY. ROOT CAUSE COULD NOT BE DETERMINED FROM THE INFORMATION PROVIDED. BASED ON THE INFORMATION AVAILABLE, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY. NO CORRECTIVE ACTION IS REQUIRED AT THIS TIME. THIS ISSUE WILL BE SUBJECT TO TRACKING AND TRENDING.

Description of Event or Problem · 1

CUSTOMER IN (B)(6) REPORTED POTENTIAL (B)(6) COCAINE (COC) AND BENZODIAZEPINES (BZO) RESULT WITH THE LATERAL FLOW DRUG SCREEN TEST VS. THE RESULT FROM REFERENCE LAB GCMS OF ZERO COC AND BZO. NO SPECIFIC PATIENT INFORMATION WAS AVAILABLE. CUSTOMER ONLY INDICATED THE 'COCAINE' PATIENT WAS EITHER ON NOTHING OR DIFFERENT MEDICATIONS; BZO PATIENT WAS ON NOTHING OR ONLY IBUPROFEN.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
816420	(COC/AMP/EDDP100/MOP/BZO)MULTI-DRUG ONE STEP 5 DRUG SCREEN TEST PANEL (URINE)	DRUG OF ABUSE TEST	DIO		4532822079	DN-DOA5040102

Patients

Seq	Age	Sex	Outcome	Treatment
1