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

Catalog Number RD701

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/14/2014

Event Type  malfunction  

Event Description

The account reported abnormal reaction flags and imprecision on thyroxine stimulating hormone (tsh) qc samples with dimension® chemistry wash lot rd41041 installed on the dimension system.Patient results were not reported to the physician.Patient treatment was not altered or prescribed on the basis of the discrepant qc sample results.There was no report of adverse health consequences as a result of the discrepant qc sample 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.The july 2014 recall notice stated that siemens would be 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.Subsequently, siemens issued an urgent medical device recall update dated august 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 accounts who had previously had lot rd41041 on their system: if available, move ctni, ltni, pbnp, lpbn, tsh, and ft4 testing to an alternate instrument, either a dimension system which was not exposed to chemistry wash lot rd41041 or an instrument with an alternate methodology or platform.If the above action is not possible, patient samples must be bracketed with low level qc for all affected assays.Before reporting patient results, qc values processed before and after the patient sample(s) must be within acceptable qc limits.If any qc values are not acceptable, do not report the patient result(s) and contact siemens for direction on further actions.The update stated that siemens would contact customers with details to schedule remedial actions to prevent further contamination of their dimension system.

• 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: 4240896
• MDR Text Key: 4987650
• Report Number: 2517506-2014-00317
• 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: 10/15/2014

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: 10/15/2014
• Initial Date FDA Received: 11/10/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/13/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: 2517506-07/15/2014-003-C
• Patient Sequence Number: 1