MAUDE Adverse Event Report: RADIOMETER MEDICAL APS PICO70

Model Number	956-522
Medical Device Problem Code	Corroded (1131)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	07/10/2019
Type of Reportable Event	Malfunction
Event or Problem Description
According to the complaint, it looks like corrosion attached on the surface of the needles pico70 (956-522).
Additional Manufacturer Narrative
On august 8th 2019 radiometer decided to recall the affected lot (bu51).The product has only been distributed in china and the problem has only been reported from china, why us is not affected.The root cause of corrosion is exposure to high concentrations of chloride containing gas/liquid in a high temperature & high humidity environment.Analysis and investigations have been made to support this root cause: corrosion identified on corroded needles.Smell of chloride of samplers with corroded needles.By testing of reference samples, it has been concluded that exposure to chloride occurs after samplers have been shipped to china.Investigation of each step of the supply chain has been performed.Use of chloride containing gases has not been identified anywhere in the supply chain, and would not be present during normal handling/storage/shipping.

• Brand Name: PICO70
• Common Device Name: PICO70
• Manufacturer (Section D): RADIOMETER MEDICAL APS; aakandevej 21; broenshoej, 2700 ; DA 2700
• MDR Report Key: 8792594
• Report Number: 3002807968-2019-00032
• Device Sequence Number: 1832517
• Product Code: JKA
• UDI-Device Identifier: 05700699565228
• UDI-Public: (01)05700699565228(17)200909(10)BU51
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 08/20/2019

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: 09/09/2020
• Device Model Number: 956-522
• Device Catalogue Number: 956-522
• Device Lot Number: BU-51
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/12/2019
• Supplement Date Received by Manufacturer: 08/08/2019
• Initial Report FDA Received Date: 07/16/2019
• Supplement Report FDA Received Date: 08/20/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1