MAUDE Adverse Event Report: RADIOMETER MEDICAL APS PICO70

Model Number	956-525
Medical Device Problem Code	Contamination of Device Ingredient or Reagent (2901)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	05/15/2019
Type of Reportable Event	Malfunction
Event or Problem Description
According to the complaint, the customer noticed a foreign material around the needle.
Additional Manufacturer Narrative
D10 in initial mdr report should have been "yes".Radiometer has not been able to establish the root cause.It is considered likely that the issue is related to the opening of a plastic bag in the cleanroom.

• Brand Name: PICO70
• Common Device Name: PICO70
• Manufacturer (Section D): RADIOMETER MEDICAL APS; aakandevej 21; broenshoej, 2700 ; DA 2700
• MDR Report Key: 8648760
• Report Number: 3002807968-2019-00022
• Device Sequence Number: 2182768
• Product Code: JKA
• UDI-Device Identifier: 05700699565259
• UDI-Public: (01)05700699565259(17)201006(10)BX50
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K962158
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/10/2020

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: No Information
• Device Expiration Date: 10/06/2020
• Device Model Number: 956-525
• Device Catalogue Number: 956-525
• Device Lot Number: BX-50
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 05/17/2019
• Supplement Date Received by Manufacturer: 01/03/2020
• Initial Report FDA Received Date: 05/29/2019
• Supplement Report FDA Received Date: 01/10/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1