MAUDE Adverse Event Report: RADIOMETER MEDICAL APS MEMBRANE BOX FOR CREA A AND CREA B

Catalog Number 942-073

Device Problem Incorrect Or Inadequate Test Results (2456)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Event Description

The customer has reported that the qc level 1 results on crea, after membrane change, jumped from 223 to 248 (range 214 to 294) and then after 7-8 days the qc results started to drift downwards to near low range until the crea electrodes are membraned again.The same was happening on the qc level 2.Three lots (0524, 0528 and 0529) of crea a and b membranes are mentioned in the complaint, but specific data for each lot has not been provided.This complaint contains the mfg data for lot 0528.Mdr 3002807968-2014-00049 is for lot 0524.Mdr 3002807968-2014-00051 is for lot 0529.

Manufacturer Narrative

The problem regarding negative drift on crea was discovered during internal tests.(b)(4) was opened to investigate the root cause of this negative drift.A health risk assessment (hra) has been made for this problem (b)(4) and conclusion is: it is considered remotely possible that the described error by the abl800 flex will cause an injury or impairment requiring professional medical intervention, but not including injuries requiring intervention to preclude irreversible impairment or damage.In this case no pt related problems was reported, since the problem was identified on the qc measurements.The case was received 2014-09-11, but initially there was no indication that this type of malfunction would lead to potential clinical problems.However based on further investigations performed by r&d (documented in (b)(4)) it was identified on (b)(4) 2014, in hra, that there is a potential clinical problem if the customer does not run regular qc.This case is reported since the membranes do not meet their specs related to in use lifetime and this has resulted in the initiation of a recall.The results and conclusion of the root cause investigation will be reported in the recall.

• Brand Name: MEMBRANE BOX FOR CREA A AND CREA B
• Type of Device: MEMBRANE BOX FOR CREA A AND CREA B
• Manufacturer (Section D): RADIOMETER MEDICAL APS; bronshoj 2700 ; DA 2700
• Manufacturer Contact: akandevej 21; bronshoj 2100 ; 8273827
• MDR Report Key: 4281172
• MDR Text Key: 5033950
• Report Number: 3002807968-2014-00050
• Device Sequence Number: 1
• Product Code: CHL
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K051968
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative,Distributor
• Reporter Occupation: Not Applicable
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 10/23/2014

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: 07/31/2015
• Device Catalogue Number: 942-073
• Device Lot Number: 0528
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/23/2014
• Initial Date FDA Received: 11/07/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/01/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: 3002807968-10/29/14-005-
• Patient Sequence Number: 1