MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC - GLASGOW DIMENSION® CLINICAL CHEMISTRY SYSTEM; PHENYTOIN FLEX® REAGENT CARTRIDGE

Catalog Number DF64

Device Problems Calibration Error (1078); Incorrect Or Inadequate Test Results (2456)

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

Event Date 08/22/2014

Event Type  malfunction  

Event Description

Discrepant phenytoin (ptn) results were obtained on qc samples when attempting to calibrate ptn lot fa5154.The calibration was not accepted and patient results were not reported to physicians.There is no indication that patient treatment was altered or prescribed on the basis of the failed ptn calibration.There is no indication of adverse impact to patients due to the failed ptn calibration.

Manufacturer Narrative

Siemens healthcare diagnostics has confirmed customer complaints of imprecision and inaccuracy with ptn flex lot fa5154.Internal testing has confirmed a low absorbance range between the levels 1 and 5 calibrators with this lot resulting in the potential for a positive or negative bias and imprecision across the ptn assay range.Internal studies demonstrated the bias is variable across the assay range from 9-38%.The highest degree of bias is observed below the therapeutic range of 10-20 ug/ml (39.6-79.2 umol/l).The reagent blank absorbance for ptn lot fa5154 may also generate abnormal reaction flags.Siemens issued an urgent medical device recall communication (b)(4) dated september 2014 to customers who had ordered ptn lot fa5154 advising them to discontinue the use of the lot.Siemens offered a no charge replacement with a non-impacted lot of phenytoin flex reagent cartridges.

• Brand Name: DIMENSION® CLINICAL CHEMISTRY SYSTEM
• Type of Device: PHENYTOIN FLEX® REAGENT CARTRIDGE
• 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: 4131253
• MDR Text Key: 4935589
• Report Number: 2517506-2014-00343
• Device Sequence Number: 1
• Product Code: DIP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K911056
• 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: 09/12/2014

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: Medical Technologist
• Device Expiration Date: 06/03/2015
• Device Catalogue Number: DF64
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/12/2014
• Initial Date FDA Received: 10/01/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/04/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: 2517506-09-24-2014-005C
• Patient Sequence Number: 1