MAUDE Adverse Event Report: ALERE SAN DIEGO, INC. ACCEAVA MONO TEST STRIP 25T (92404); MONONUCLEOSIS RAPID TEST

Model Number IMO-411

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  Injury  

Manufacturer Narrative

Intake unable to speak with customer directly.Kit not being returned.Results pending investigation.

Event Description

Unspecified date: customer reports the glass capillary tubes provided in the acceava mono ii test kit frequently break when attempting to collect the sample from the patient.No further information available.Intake was unable to speak to the customer directly; issue was reported by an abbott representative.No known impact to the operator or patient.Although no death or serious injury was reported at intake, as the capillary tube is glass and contains patient specimen, there is the potential for harm if the issue were to recur.Therefore, this mdr is being conservatively filed.Although further information was requested, no further information was provided.

Manufacturer Narrative

Based on medical review and input, breakage of the capillary tubes while collecting sample from a fingerstick would not cause any adverse event, death or serious injury, therefore, this serious injury mdr was filed in error.Please disregard mdr.

Event Description

Based on medical review and input, breakage of the capillary tubes while collecting sample from a fingerstick would not cause any adverse event, death or serious injury, therefore, this serious injury mdr was filed in error.Please disregard mdr.

• Brand Name: ACCEAVA MONO TEST STRIP 25T (92404)
• Type of Device: MONONUCLEOSIS RAPID TEST
• Manufacturer (Section D): ALERE SAN DIEGO, INC.; 9975 summers ridge rd.; san diego CA 92121
• MDR Report Key: 9679340
• MDR Text Key: 178128133
• Report Number: 2027969-2020-00011
• Device Sequence Number: 1
• Product Code: KTN
• Combination Product (y/n): N
• PMA/PMN Number: K042272
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 02/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Model Number: IMO-411
• Device Lot Number: NOT PROVIDED
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/08/2020
• Initial Date FDA Received: 02/06/2020
• Supplement Dates Manufacturer Received: 02/10/2020
• Supplement Dates FDA Received: 02/11/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other