MAUDE Adverse Event Report: BECKMAN COULTER ACCESS HYPERSENSITIVE HTSH REAGENT; RADIOIMMUNOASSAY, THYROID-STIMULATING HORMONE, PRODUCT CODE: JLW

Catalog Number 33820

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/31/2016

Event Type  malfunction  

Manufacturer Narrative

The access hypersensitive htsh reagent was not returned for evaluation.The customer provided photographic evidence to indicate a metal nut was introduced into the access hypersensitive htsh reagent pack.The beckman coulter reagent pack fill line was inspected and the source of the metal nut could not be determined.Filling batch records were examined and there is evidence to suggest the timing of the foreign object introduction was likely to have occurred prior to filling the reagent packs.This lot of access hypersensitive htsh reagent met all release specifications and the fill line was in its validated state.The cause of this event is likely due to a metal nut entering the pack during the manufacturing process.(b)(4).

Event Description

The customer reported receiving a thyroid-stimulating hormone (access hypersensitive htsh) reagent pack with a foreign object sealed inside well three (3).The foreign object was confirmed to be a metal nut that was sealed inside well three of the access hypersensitive htsh reagent pack.Well three is designed to contain a clear buffered saline.Well three of the reported access hypersensitive htsh reagent pack contained a metal screw and the liquid had turned blue.The access hypersensitive htsh reagent pack was not placed on the instrument.No impact to patient results associated with this event.

• Brand Name: ACCESS HYPERSENSITIVE HTSH REAGENT
• Type of Device: RADIOIMMUNOASSAY, THYROID-STIMULATING HORMONE, PRODUCT CODE: JLW
• Manufacturer (Section D): BECKMAN COULTER; 1000 lake hazeltine drive; chaska MN 55318
• Manufacturer (Section G): BECKMAN COULTER; 1000 lake hazeltine drive; chaska MN 55318
• Manufacturer Contact: angela kilian ; 1000 lake hazeltine drive; chaska, MN 55318 ; 9523681330
• MDR Report Key: 5967280
• MDR Text Key: 55277432
• Report Number: 2122870-2016-00451
• Device Sequence Number: 1
• Product Code: JLW
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K042281
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/31/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/21/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2017
• Device Catalogue Number: 33820
• Device Lot Number: 626685
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/31/2016
• Date Device Manufactured: 06/26/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1