MAUDE Adverse Event Report: ALERE SAN DIEGO HENRY SCHEIN MONO TEST DEVICE 20T; MONONUCLEOSIS REAGENT TEST KIT

Model Number IMO-402

Device Problem Leak/Splash (1354)

Patient Problem Exposure to Body Fluids (1745)

Event Type  Injury  

Manufacturer Narrative

Results pending completion of investigation.

Event Description

A lab technician was inserting the dispensing bulb on a mono test kit when the capillary tube broke.At the time of the complaint, the customer reported a potential for exposure.The user was wearing ppe during use of the product.On (b)(6) 2020, it was reported that the blood did get on the face and hair of the lab technician.The lab technician was tested due to potential exposure to a hazardous fluid.No injuries occurred.Although requested, no further information was received.

Manufacturer Narrative

D4: lot number, mon9062004.Expiration date, 5/26/2021.Udi, (b)(4).D10: device returned to manufacturer, 04/24/2020.G4: date of the investigation conclusion, 05/04/2020.H3: yes.Investigation conclusion: capillary tubes from retained and returned kits from the reported lot number were visually inspected and no abnormalities were observed.All capillary tubes met the specification for outer diameter.The capillary tubes were used to collect and dispense fingerstick whole blood samples, and the reported issue was not replicated.The case details were reviewed along with the complaint history for the reported issue and no indications of a systemic issue were identified.Manufacturing batch record review did not uncover any relevant non-conformances and found that the lot met quality control specifications.The risk of potential harm to the user from a broken capillary tube was assessed.The severity rating is marginal with a probability of occurrence rating of improbable.The risk is considered to be reduced as far as possible.A root cause could not be determined from the available information as the reported issue was not replicated during testing of either retention or returned product.Complaints are tracked and trended on a monthly basis.Per the package insert, wear protective clothing such as laboratory coats, disposable gloves and eye protection when specimen samples are assayed.

• Brand Name: HENRY SCHEIN MONO TEST DEVICE 20T
• Type of Device: MONONUCLEOSIS REAGENT TEST KIT
• Manufacturer (Section D): ALERE SAN DIEGO; 9975 summers ridge rd; san diego, ca
• MDR Report Key: 9908585
• MDR Text Key: 192734779
• Report Number: 2027969-2020-00017
• 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: distributor,health profession
• Type of Report: Initial,Followup
• Report Date: 05/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/26/2020
• Device Model Number: IMO-402
• Device Lot Number: MON9062004
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/24/2020
• Initial Date Manufacturer Received: 03/25/2020
• Initial Date FDA Received: 03/31/2020
• Supplement Dates Manufacturer Received: 05/04/2020
• Supplement Dates FDA Received: 05/04/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other