MAUDE Adverse Event Report: ROCHE DIAGNOSTICS COBAS 8000 C 702 MODULE; CLINICAL CHEMISTRY ANALYZER

Model Number C702

Device Problem Incorrect Or Inadequate Test Results (2456)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/15/2018

Event Type  malfunction  

Manufacturer Narrative

Unique identifier (udi)#: (b)(4).

Event Description

The customer stated that between (b)(6) 2018, they had erroneous results for one patient sample tested for gluc3 glucose hk gen.3 (glu) and one patient sample tested for ca2 calcium gen.2 (ca) on a cobas 8000 c 702 module (c702).The initial erroneous results for both samples were reported outside of the laboratory and questioned by a physician.The samples were pulled and repeated.The repeat results were believed to be correct and the customer stated that they will issue amended reports.The first sample initially resulted with a glu value of 175 mg/dl accompanied by a data flag.The physician questioned the glu value since the patient had a normal a1c value.The sample was repeated on (b)(6) 2018, resulting as 86 mg/dl.The second sample, from a (b)(6) male patient born on (b)(6) 1949, initially resulted with a ca value of 5.8 mg/dl accompanied by a data flag on (b)(6) 2018.The sample was automatically repeated by the analyzer, resulting as 5.8 mg/dl.The 5.8 mg/dl value was reported outside of the laboratory and questioned by the physician.The sample was repeated on (b)(6) 2018, resulting as 9.1 mg/dl.The patients were not adversely affected.The glu reagent lot number was 302652.The reagent expiration date was asked for, but not provided.The ca reagent lot number was 318812.The reagent expiration date was asked for, but not provided.The field service engineer determined that the sample probe position was outside of the rinse well, so the probe was not being rinsed and was not aligned properly.He replaced the probe and aligned it.He checked the instrument performance, other alignments, optics, other probes, and rinse mechanisms.He adjusted cuvette covers.The customer ran precision studies and ran controls; all results were within specified ranges with no outliers or errors.Investigations have determined that the issue was solved by the service actions.

• Brand Name: COBAS 8000 C 702 MODULE
• Type of Device: CLINICAL CHEMISTRY ANALYZER
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• Manufacturer (Section G): HITACHI HIGH TECH CORP.; 882 ichige hitachinaka; na; ibaraki 312-8 504; JA 312-8504
• Manufacturer Contact: michael leslie ; 9115 hague road; na; indianapolis, IN 46250 ; 3175214343
• MDR Report Key: 7659040
• MDR Text Key: 113409117
• Report Number: 1823260-2018-02187
• Device Sequence Number: 1
• Product Code: JJE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K100853
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/03/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/03/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: C702
• Device Catalogue Number: 06473245001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/20/2018
• 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
• Patient Age: 14 YR