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

Model Number	DCJLR-N
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	Laceration(s) (1946)
Date of Event	05/05/2018
Type of Reportable Event	Malfunction
Additional 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 or Problem 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
• Common Device Name: PLASMA, COAGULATION CONTROL
• Manufacturer (Section D): ACCRIVA DIAGNOSTICS; 6260 sequence drive; san diego CA 92121
• MDR Report Key: 7509440
• Report Number: 2250033-2018-00011
• Device Sequence Number: 16568176
• Product Code: GGN
• UDI-Device Identifier: 10711234170243
• UDI-Public: 10711234170243
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K120977
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: 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
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/06/2018
• Initial Report FDA Received Date: 05/11/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 28 YR
• Patient Weight: 66