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

Model Number DCJLR-A

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem Laceration(s) (1946)

Event Date 06/25/2018

Event Type  malfunction  

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 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 Description

Follow-up #1.

Manufacturer Narrative

(b)(4).

• Brand Name: DIRECTCHECK ACT-LR QUALITY CONTROL, ABNORMAL
• Type of Device: PLASMA, COAGULATION CONTROL
• Manufacturer (Section D): ACCRIVA DIAGNOSTICS; 6260 sequence drive; san diego CA 92121
• MDR Report Key: 7640141
• MDR Text Key: 112456133
• Report Number: 2250033-2018-00014
• Device Sequence Number: 1
• Product Code: GGN
• UDI-Device Identifier: 10711234107089
• UDI-Public: 0110711234107089
• Combination Product (y/n): N
• PMA/PMN Number: K120977
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: 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 Manufacturer Received: 06/26/2018
• Initial Date FDA Received: 06/26/2018
• Supplement Dates Manufacturer Received: 06/29/2018
• Supplement Dates FDA Received: 09/27/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1