MAUDE Adverse Event Report: ROCHE DIABETES CARE, INC. SOFTCLIX ® LANCETS

Lot Number ASKU

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Needle Stick/Puncture (2462)

Event Date 12/05/2023

Event Type  Injury  

Event Description

The customer reported that she bought the accu-chek guide me meter kit at the pharmacy on 12/4/2023.At this time the pharmacy attendant instructed the customer on how to use the lancet device and meter.The attendant advised her that upon opening the box there was already a lancet loaded inside of the accu-chek softclix device.The next day, 12/5/2023, the customer used the lancet that was loaded inside of the softlcix device and performed a needlestick.The customer stated that she then noticed that the lancet had been previously used by another person because there was a blood glucose measurement recorded in the history of the meter from (b)(6) 2023.The customer went to the infectious disease hospital and was treated with a "cocktail of hiv medications." the names of the medications were not provided.

Manufacturer Narrative

The event occurred outside of the united states while this product is not sold in the united states, it is like or similar to a product marketed in the united states h3 other text : the customer no longer has the product to return.

• Brand Name: SOFTCLIX ® LANCETS
• Type of Device: LANCET
• Manufacturer (Section D): ROCHE DIABETES CARE, INC.; 9115 hague road; indianapolis IN 46250 0457
• Manufacturer (Section G): FACET TECHNOLOGIES LLC; 3900 north commerce drive; na; atlanta GA 30344
• Manufacturer Contact: john krug ; 9115 hague road; na; indianapolis, IN 46250-0457 ; 3175212484
• MDR Report Key: 18371112
• MDR Text Key: 331059011
• Report Number: 3011393376-2023-02859
• Device Sequence Number: 1
• Product Code: FMK
• Combination Product (y/n): N
• Reporter Country Code: BR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/05/2023
• Initial Date FDA Received: 12/21/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 37 YR
• Patient Sex: Female