MAUDE Adverse Event Report: ROCHE DIAGNOSTICS COBAS INTEGRA 400 PLUS; CLINICAL CHEMISTRY ANALYZER

Model Number I400+

Device Problem Low Test Results (2458)

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

Event Date 07/21/2017

Event Type  malfunction  

Manufacturer Narrative

Unique identifier (udi)#: (b)(4).This event occurred in (b)(6).Phone was provided as "(b)(6)".

Event Description

The customer received a questionable low crplx c-reactive protein (latex) result for one patient sample.The initial result was 0.24 mg/dl and was reported to the physician who questioned the result.The repeat result was 20.12 mg/dl.There was no allegation of an adverse event.The reagent lot number was 238078.The expiration date was requested but was not provided.The provided calibration and qc were reviewed and did not indicate any issues.

Manufacturer Narrative

A specific root cause could not be identified.Based on review of the provided qc data, a general issue was not suspected.The customer was not following the tube manufacturer's recommendation for centrifugation parameters which may have affected the sample quality.The customer replaced the probes and no further issues were noted.

• Brand Name: COBAS INTEGRA 400 PLUS
• Type of Device: CLINICAL CHEMISTRY ANALYZER
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• Manufacturer (Section G): ROCHE INSTRUMENT CENTER AG TEGIMENTA; forrenstrasse; na; rotkreuz 6343 ; SZ 6343
• Manufacturer Contact: michael leslie ; 9115 hague road; na; indianapolis, IN 46250 ; 3175214343
• MDR Report Key: 6777655
• MDR Text Key: 82702516
• Report Number: 1823260-2017-01659
• Device Sequence Number: 0
• Product Code: DCN
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K951595
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/18/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/09/2017
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: I400+
• Device Catalogue Number: 03245233001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/21/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1