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

Model Number	DCJLR-A
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	Laceration(s) (1946)
Date of Event	06/25/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Method: actual device not evaluated.Dhr review was not performed because the complaint is unrelated to product performance or packaging.Results: no results available since no evaluation performed.Conclusion: human factors issue.Training deficiency.Device not returned.Accriva diagnostics has requested all data required for form 3500a.
Event or Problem Description
Healthcare professional called to report an end-user injury that occurred during dispensing a directcheck act-lr abnormal liquid quality control.Lyophilized control material is packaged in a glass ampule inside a crushable plastic dropper vial containing diluent.Each directcheck control includes a set of protective sleeves intended to safeguard end-users from potential injury while handling the control.The end-user utilized the protective sleeve when he crushed the ampule to mix the reagent and diluent.He removed the protective sleeve after mixing and squeezed the vial to dispense the reconstituted control.When doing so, a shard of the glass ampuole penetrated the vial and caused a small cut to the right middle finger.The end-user washed the finger with soap and water, then affixed a band aid.Severe bleeding or other medical complications were recorded.
Event or Problem Description
Follow-up #1.
Additional Manufacturer Narrative
(b)(4).

• Brand Name: DIRECTCHECK ACT-LR QUALITY CONTROL, ABNORMAL
• Common Device Name: PLASMA, COAGULATION CONTROL
• Manufacturer (Section D): ACCRIVA DIAGNOSTICS; 6260 sequence drive; san diego CA 92121
• MDR Report Key: 7640141
• Report Number: 2250033-2018-00014
• Device Sequence Number: 19381790
• Product Code: GGN
• UDI-Device Identifier: 10711234107089
• UDI-Public: 0110711234107089
• Combination Product (Y/N): N
• Initial Reporter State: ID
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 06/28/2018

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: 06/30/2019
• Device Model Number: DCJLR-A
• Device Catalogue Number: DCJLR-A
• Device Lot Number: B8DLA002
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 06/26/2018
• Supplement Date Received by Manufacturer: 06/29/2018
• Initial Report FDA Received Date: 06/26/2018
• Supplement Report FDA Received Date: 09/27/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1