MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC - GLASGOW DIMENSION® CLINICAL CHEMISTRY SYSTEM; CHEMISTRY WASH

Catalog Number RD701

Device Problem High Test Results (2457)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/11/2014

Event Type  malfunction  

Event Description

Falsely elevated n-terminal pro-brain natriuretic peptide (pbnp) results were obtained on qc samples with chemistry wash lot rd41041 on the dimension instrument.No patient results were reported to physicians.Qc results returned to within laboratory ranges with an alternate lot of chemistry wash on the instrument.Patient treatment was not altered or prescribed on the basis of the falsely elevated pbnp qc results.There was no report of adverse health consequences as a result of the falsely elevated pbnp qc results.

Manufacturer Narrative

Siemens has confirmed bacterial contamination in chemistry wash lot rd41041.A positive bias will be observed on ctni, ltni, tsh, pbnp and lpbn and a negative bias will be seen on ft4 when this lot is first placed on the instrument without recalibration of methods.Recalibration of these assays when using this lot will not correct the problem and may cause falsely high or low results.Siemens issued an urgent medical device recall dated july 2014, communication # (b)(4), to all accounts who had received the impacted lot.Customers were advised of the immediate remedial actions to be taken by the customer: immediately discontinue use and discard all inventory of chemistry wash lot rd41041.- if this lot was never in use on the instrument, no further action is needed.- if this lot had been in use: place an alternate lot of chemistry wash on the dimension system.Prime the new bottle of chemistry wash 30 times.Recalibrate the ctni, ltni, tsh, ft4, pbnp and/or lpbn assays using the alternate lot of chemistry wash onboard.For the listed assays, process quality control every 8 hours.In the urgent medical device recall communication it was stated that siemens was shipping replacement product at no charge for all orders filled with lot rd41041.As an additional precaution, a siemens customer service engineer would be making a visit to decontaminate the system(s) of customers who have used lot rd41041.

• Brand Name: DIMENSION® CLINICAL CHEMISTRY SYSTEM
• Type of Device: CHEMISTRY WASH
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC - GLASGOW; glasgow business community; 500 gbc drive; newark DE 19714
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS INC - GLASGOW; glasgow business community; 500 gbc drive; newark DE 19714
• Manufacturer Contact: james morgera ; glasgow business community; po box 6101; newark, DE 19714-6101 ; 3026318356
• MDR Report Key: 3979561
• MDR Text Key: 16849867
• Report Number: 2517506-2014-00119
• Device Sequence Number: 1
• Product Code: JMG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K963498
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Medical Technologist
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 07/15/2014

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: Other
• Device Expiration Date: 10/13/2014
• Device Catalogue Number: RD701
• Device Lot Number: RD41041
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/15/2014
• Initial Date FDA Received: 08/05/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/13/2014
• Is the Device Single Use?: No
• Removal/Correction Number: 2517506-07/15/2014-003-C
• Patient Sequence Number: 1