MAUDE Adverse Event Report: ACCRIVA DIAGNOSTICS DIRECTCHECK ACT-LR QUALITY CONTROL, NORMAL; PLASMA, COAGULATION CONTROL

Model Number DCJLR-N

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem Laceration(s) (1946)

Event Date 05/05/2018

Event Type  malfunction  

Manufacturer Narrative

This mdr submitted electronically on 05/11/2018 references accriva diagnostics' complaint number (b)(4).Method code: actual device not evaluated.Dhr review was not performed because the complaint is unrelated to product performance or packaging.Results code: no results available since no evaluation performed.Conclusion codes: human factors issue.Training deficiency.Device not returned.Accriva diagnostics has requested all data required for form 3500a.Fields for which data were not obtainable or are not applicable are intentionally left blank.

Event Description

Healthcare professional reported that an end user sustained an injury while handling a directcheck quality control.This control is packaged in a glass ampule inside a crushable plastic dropper vial containing diluent.The end user crushed the vial to reconstitute the control and sustained a small cut to her right index finger which was caused by a shard of glass.The end-user wore gloves but failed to utilize the protective sleeve provided with the product.The purpose of the sleeve is to safeguard the end user against potential injury while handling the control.The end user filed a report with her supervisor and was seen by occupational health.No lab tests were drawn and general site care was performed.The next day, the end user followed up with occupational health.The puncture site showed no problems and was healing.

• Brand Name: DIRECTCHECK ACT-LR QUALITY CONTROL, NORMAL
• Type of Device: PLASMA, COAGULATION CONTROL
• Manufacturer (Section D): ACCRIVA DIAGNOSTICS; 6260 sequence drive; san diego CA 92121
• Manufacturer (Section G): ACCRIVA DIAGNOSTICS; 6260 sequence drive; san diego CA 92121
• Manufacturer Contact: jon mcdermed ; 6260 sequence drive; san diego, CA 92121 ; 8582632490
• MDR Report Key: 7509440
• MDR Text Key: 108260732
• Report Number: 2250033-2018-00011
• Device Sequence Number: 1
• Product Code: GGN
• UDI-Device Identifier: 10711234170243
• UDI-Public: 10711234170243
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K120977
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/11/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/01/2018
• Device Model Number: DCJLR-N
• Device Catalogue Number: DCJLR-N
• Device Lot Number: H7DNL023
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/06/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/01/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 28 YR
• Patient Weight: 66