MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH N LATEX HCY

Catalog Number OPAX032 SMN10445973

Device Problem Low Test Results (2458)

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

Event Date 08/11/2016

Event Type  malfunction  

Manufacturer Narrative

Siemens healthcare diagnostics has observed a reduced once-opened stability and a reduced on-board stability for the affected lot 802907632 that may result in erroneously reduced or elevated homocysteine.This stability issue may lead to a higher than expected lot-to-lot variation and impaired product performance.Urgent medical device correction (umdc) (b)(4) was sent to customers in the united states on january 11, 2017 and corresponding urgent field safety notice (ufsn) (b)(4) was sent to all outside us customers who have been shipped the impacted lot, 802907632.The umdc and ufsn titled "n latex hcy and n latex hcy (bcs® xp) lot 802907632 does not meet once-opened and onboard stability claims" and instructs customers to discontinue use and to discard the lot.

Event Description

Discordant low homocysteine (hcy) results were obtained with lot 802907632 in a lot to lot comparison study with an alternate lot 802905645 on the bn prospect instrument.Patient results of the comparison study were not reported to the physician(s).All controls run with lots 802907632 and 802905645 were within range and that there were no instrument errors.There are no reports of patient intervention or adverse health consequences due to the discordant low hcy results.

• Brand Name: N LATEX HCY
• Type of Device: N LATEX HCY
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH; emil von behring strasse 76; marburg, D-350 41; GM D-35041
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH; emil von behring strasse 76; marburg, D-350 41; GM D-35041
• Manufacturer Contact: james morgera ; glasgow business community; 500 gbc drive po box 6101; newark, DE 19714-6101 ; 3026318356
• MDR Report Key: 6258914
• MDR Text Key: 65038809
• Report Number: 9610806-2017-00009
• Device Sequence Number: 1
• Product Code: LPS
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K052788
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Health Professional
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 01/17/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/17/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Medical Technologist
• Device Expiration Date: 02/13/2017
• Device Catalogue Number: OPAX032 SMN10445973
• Device Lot Number: 802907632
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/20/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/03/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: 2432235-01/11/2017-001-R
• Patient Sequence Number: 1